(129 days)
No
The document describes a sunlamp product using UV, red, and blue light for tanning, with no mention of AI or ML technology in its operation or features.
No.
The intended use explicitly states "exclusively for aesthetic tanning of the human skin," which does not constitute a therapeutic purpose.
No
This device is a sunlamp product intended exclusively for aesthetic tanning of human skin. It uses UV radiation for tanning, not for diagnosing any medical conditions.
No
The device description explicitly states the primary technical components are artificial sources of UV radiation and a mechanical structure, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "aesthetic tanning of the human skin." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description focuses on the technical components related to UV radiation and light spectra for tanning. There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection or measurement of specific analytes.
- Diagnosis, monitoring, or prediction of diseases or conditions.
- Performance metrics like sensitivity, specificity, PPV, NPV, which are crucial for evaluating diagnostic accuracy.
In summary, the device's purpose is to induce tanning through UV and other light exposure, which falls under the category of aesthetic or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
Product codes
LEJ
Device Description
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience. Optimal tanning results are achieved due to the synergistic combination of light spectra.
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human skin
Indicated Patient Age Range
18 or above
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K190173, K151400 CV344_PF_100003421_V01, K180555, K151400
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 1, 2022
JK-Holding GmbH Juergen Gerstenmeier Official Applicant Koehlershohner Strasse 60 Windhagen, Rheinland-Pfalz 53578 Germany
Re: K220500
Trade/Device Name: Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline Regulation Number: 21 CFR 878.4635 Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products Regulatory Class: Class II Product Code: LEJ Dated: May 20, 2022 Received: May 31, 2022
Dear Juergen Gerstenmeier:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220500
Device Name
Ergoline Vitality Total Light, Ergoline Vitality Hybrid Light, Ergoline Vitality Pure Light, Planet Fitness TLT by Ergoline, Planet Fitness HLT by Ergoline, Planet Fitness PLT by Ergoline
Indications for Use (Describe)
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Chapter 5 510(k) Summary of Safety and Effectiveness
4
510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, JK-HOLDING GmbH herewith submits a Summary of Safety and Effectiveness.
This 510(k) summary includes the bundles for device trade names for Ergoline Vitality Total Light, Ergoline Vitality Hybrid Light, Ergoline Vitality Pure Light, Planet Fitness TLT by Ergoline, Planet Fitness HLT by Ergoline, Planet Fitness PLT by Ergoline & variant units which meet the requirements of 21 CFR 807.92
| Manufacturer Information: | JK-Produkts GmbH
Rottbitzer Strasse 69
53604 Bad Honnef
Germany
Phone: +49 (0) 2224 / 818-140
Fax: +49 (0) 2224 / 818-166 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9615023
Owner/Operator Number: 9034303 |
| Submitter Information: | JK-HOLDING GmbH
Koehlershohner Strasse 60
53578 Windhagen
Phone: +49 (0) 2224 / 818-0
Fax: +49 (0) 2224 / 818-116 |
| Official Correspondent: | Juergen Gerstenmeier
Koehlershohner Strasse 60
53578 Windhagen
Germany
Phone: +49 (0) 2224 / 818-330
Email: juergen.gerstenmeier@jk-group.net |
| US Agent (Contact): | Marie Merrill
JK PRODUCTS & SERVICES, INC.
411 West Washington Ave Suite B
Jonesboro , AR 72401
Phone: 870 761 8906
Fax: 870 9359046
Email: marie.merrill@jkamerica.com |
| Device trade name: | Ergoline Vitality Total Light 3
Planet Fitness 50/4 TLT by Ergoline
Planet Fitness 42/3 TLT by Ergoline
Ergoline Vitality Hybrid Light 3
Ergoline Vitality Hybrid Light
Planet Fitness 50/4 HLT by Ergoline
Planet Fitness 46/3 HLT by Ergoline |
5
Ergoline Vitality Pure Light 3 Ergoline Vitality Pure Light Planet Fitness 50/4 PLT III by Ergoline Planet Fitness 50/4 PLT by Ergoline Planet Fitness 46/3 PLT by Ergoline Planet Fitness 42/3 PLT by Ergoline
Date Prepared: February 16th, 2022
6
Table of contents
| 1 | Table of contents | 5 | |
|---|---|---|---|
| 1.1 | Device(s) Identification: | 5 | |
| 1.1.1 | Indications for use: | 5 | |
| 1.1.2 | Classification of all proposed device: | 6 | |
| 1.2 | Device trade name of bundle 1: | 6 | |
| 1.2.1 | Device Description: | 6 | |
| 1.2.2 | Legally marketed predicate device: | 7 | |
| Legally marketed technical referenced device: | 7 | ||
| 1.2.3 | Comparison bundle 1 to predicate device: | 8 | |
| 1.2.4 | Summary of performance testing: | 12 | |
| 1.2.5 | Conclusion: | 13 | |
| 1.3 | Device trade name of bundle 2: | 13 | |
| 1.3.1 | Device description: | 13 | |
| 1.3.2 | Legally marketed predicate device 2: | 14 | |
| 1.3.3 | Comparison bundle 2 to predicate device: | 15 | |
| 1.3.4 | Summary of performance testing: | 17 | |
| 1.3.5 | Conclusion: | 17 | |
| 1.4 | Device trade name of bundle 3: | 17 | |
| 1.4.1 | Device description: | 17 | |
| 1.4.2 | Legally marketed predicate device: | 18 | |
| Legally marketed technical referenced device: | 18 | ||
| 1.4.3 | Comparison bundle 3 to predicate device: | 19 | |
| 1.4.4 | Summary of performance testing: | 27 | |
| 1.4.5 | Conclusion: | 27 | |
| 1.5 | Device trade name of bundle 4: | 27 | |
| 1.5.1 | Device description: | 28 | |
| 1.5.2 | Legally marketed predicate device 4: | 28 | |
| 1.5.3 | Comparison bundle 4 to predicate device: | 29 | |
| 1.5.4 | Summary of performance testing: | 32 | |
| 1.5.5 | Conclusion: | 32 | |
| 1.6 | Device trade name of bundle 5: | 32 | |
| 1.6.1 | Device Description: | 33 | |
| 1.6.2 | Legally marketed predicate device 5: | 33 | |
| 1.6.3 | Comparison bundle 5 to predicate device: | 34 | |
| 1.6.4 | Summary of performance testing: | 39 | |
| 1.6.5 | Conclusion: | 39 |
7
1.1 Device(s) Identification:
In the following, 5 different bundles of devices will be presented and evaluated.
| Bundle No | Model No | Device names |
|---|---|---|
| 1 | JK 164 / 42-3 TLT-3 AC | |
| JK 164 / 42-3 TLT-3 | ||
| JK 164 / 42-3 TLT AC | ||
| JK 164 / 42-3 TLT | Planet Fitness 42/3 TLT by Ergoline | |
| Ergoline Vitality Total Light 3 | ||
| 2 | JK 164 / 42-3 PLT AC | |
| JK 164 / 42-3 PLT | Planet Fitness 42/3 PLT by Ergoline | |
| Ergoline Vitality Pure Light | ||
| 3 | JK 164 / 50-4 TLT-3 TT | |
| JK 164 / 50-4 TLT-3 | ||
| JK 164 / 50-4 HLT-3 TT | ||
| JK 164 / 50-4 HLT-3 | ||
| JK 164 / 50-4 TLT TT | ||
| JK 164 / 50-4 TLT AC | ||
| JK 164 / 50-4 TLT | Planet Fitness 50/4 TLT by Ergoline | |
| Ergoline Vitality Total Light 3 | ||
| Planet Fitness 50/4 HLT by Ergoline | ||
| Ergoline Vitality Hybrid Light 3 | ||
| 4 | JK 164 / 50-4 PLT-3 AC | |
| JK 164 / 50-4 PLT-3 | ||
| JK 164 / 50-4 PLT AC | ||
| JK 164 / 50-4 PLT | Planet Fitness 50/4 PLT III by Ergoline | |
| Ergoline Vitality Pure Light 3 | ||
| Planet Fitness 50/4 PLT by Ergoline | ||
| Ergoline Vitality Pure Light | ||
| 5 | JK 164 / 46-3 PLT AC | |
| JK 164 / 46-3 PLT | ||
| JK 164 / 46-3 HLT AC | ||
| JK 164 / 46-3 HLT | Planet Fitness 46/3 PLT by Ergoline | |
| Ergoline Vitality Pure Light | ||
| Planet Fitness 46/3 HLT by Ergoline | ||
| Ergoline Vitality Hybrid Light |
All products have an identical intended use and comparable technology.
The different devices in the bundles have different trade names, number of lamps, a different combination of light spectra and different maximum exposure times.
The basic products can be upgraded with conversion kits, consisting of stickers with the private label naming, to Soltron or further private label sunlamp products. The conversion kit only serves to label the basic product as a Soltron or further private label sunlamp product. It does not alter any technical specification or aspect of the devices.
For further information concerning conversion kits please refer to chapter 11.
1.1.1 Indications for use:
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
1.1.2 Classification of all proposed device:
| Device Classification Name: | Booth, Sun Tan |
|---|---|
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
8
1.2 Device trade names of bundle 1:
Planet Fitness 42/3 TLT by Ergoline Ergoline Vitality Total Light 3
Common name: Sunlamp product
The following table presents the different variants of the JK 164 / 42-3 Total Light Technology sunlamp product.
All variants use the same basic device technology and differ only in private labelling, exterior design, decor lighting and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 42-3 TLT-3 AC | |
| JK 164 / 42-3 TLT-3 | Planet Fitness 42/3 TLT by Ergoline |
| Ergoline Vitality Total Light 3 | |
| JK 164 / 42-3 TLT AC | |
| JK 164 / 42-3 TLT | Planet Fitness 42/3 TLT by Ergoline |
| Ergoline Vitality Total Light 3 |
1.2.1 Device Description:
Total Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience.
Optimal tanning results are achieved due to the synergistic combination of light spectra.
1.2.2 Legally marketed predicate device:
| Device Name: | Planet Fitness 42/4 Hybrid Light Technology |
|---|---|
| 510k number: | K190173 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
9
Legally marketed technical referenced device:
Sunrise 7200 Hybrid Light Technology Device Name: 510k number: K183539 Device Classification Name: Booth, Sun Tan Product Code: LEJ C.F.R. Section.: 878.4635 General & Plastic Surgery Classification Panel: Device Class: Class II
10
1.2.3 Comparison bundle 1 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate, the proposed and the technically referenced device.
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Model-No. | JK 164 / 42-3 TLT-
3 AC
JK 164 / 42-3 TLT-
3 | JK 164 / 42-3 TLT
AC
JK 164 / 42-3 TLT | JK 126 / 42-4 HT AC | JK 158 / 48-0
HT | N/A | N/A | |
| Intended Use | This sunlamp
product is intended
exclusively for
aesthetic tanning of
the human skin, for
one person at a
time, at the age of
18 or above | This sunlamp
product is intended
exclusively for
aesthetic tanning of
the human skin, for
one person at a
time, at the age of
18 or above | This sunlamp product
is intended
exclusively for
aesthetic tanning of
the human skin, for
one person at a time,
at the age of 18 or
above | N/A | Identical | N/A | |
| Number of body
lamps | 42 (28 UV lamps
and 14 UV + Red
Light lamps) | 42 (28 UV lamps
and 14 UV + Red
Light lamps) | 42 (28 UV lamps and
14 UV + Red Light
lamps) | N/A | Identical | N/A | |
| Watts of body
lamps | 200W | 160W | canopy 160W
bench 180W | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18. The safety has
been confirmed
additionally by
corresponding tests in
accordance with IEC
62471.
In terms of functionality
and safety there is no
impact due to this
difference. | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
| Lamp item
description | GENESIS PLT
Pure Light
Technology 200W
GENESIS HLT
Hybrid Light
Technology 200W
(UV&Red light) | GENESIS PLT
Pure Light
Technology 160W
GENESIS HLT
Hybrid Light
Technology 160W
(UV&Red light) | GENESIS Type U
Hybrid Performance
160 W / 180W
GENESIS Type R
Hybrid Performance
160W / 180W | N/A | Different description,
no impact, see above. | N/A | |
| Number of Total
Light-LED | 72 LED (36 Red +
36 Blue) | 36 LED (18 RED +
18 Blue) | N/A | 60 Red LED | N/A | Similar, the
irradiance
characteristics
are still
comparable as
provided under
section 18. The
safety has been
confirmed
additionally by
corresponding
tests in
accordance with
IEC 62471.
In terms of
functionality and
safety there is
no impact due to
this difference. | |
| Watts of Total
Light-LED | 100W | 50W | N/A | 45W | N/A | No impact, see
above. | |
| | Parameter | Proposed device | Proposed device | Predicate device 1 | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device |
| UV-Facials | Number of
UV-facials | 3 x 42 UVA-LED | 3 x 42 UVA-LED | 4 high pressure
lamps | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18.
In terms of functionality
and safety there is no
impact due to this
difference. | N/A |
| | Watts
facial lamp | 3 x 80W | 3 x 80W | 4x400W | N/A | No impact, see below. | N/A |
| | Facial item
description | Spectra UV-LED | Spectra UV-LED | High pressure lamp
Ergoline Ultra 520W | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18.
In terms of functionality
and safety there is no
impact due to this
difference. | N/A |
| | Filter facial
lamps | N/A | N/A | Ultra Performance
862H | N/A | No filters necessary
due to no use of high-
pressure lamps. | N/A |
| | Number of
low
pressure
facial
lamps | 2 x HLT | 2 x HLT | 3 x Type R | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18. The safety has
been confirmed
additionally by
corresponding tests in
accordance with IEC
62471.
In terms of functionality
and safety there is no
impact due to this
difference. | N/A |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
| Watts low
pressure
facial lamp | 8W | 8W | 8W | N/A | Identical | N/A | |
| Low
pressure
facial
lamps item
description | GENESIS HLT
Hybrid Light
Technology 8W | GENESIS HLT
Hybrid Light
Technology 8W | Genesis Type R
Hybrid 8W (Mix of
UV+Red Light) | N/A | Different description,
no impact, see above. | N/A | |
| Max exposure
time [min] | 12 minutes | 12 minutes | 12 minutes | N/A | Identical | N/A | |
| Electrical
Requirements | 230V 3Ø or 230V
2Ø | 230V 3Ø or 230V
2Ø | 230V 3Ø or 230V 2Ø | N/A | Identical | N/A | |
| Total power
consumption
[watts] | 11,600 W (with AC)
10,400 (w/o AC) | 8,800 W (with AC)
7,200 W (w/o AC) | 11,200 W | N/A | Similar:
The power is
different due to
different lamps.
Performance is not
impaired. | N/A | |
| Rated
overcurrent
protection
device (circuit
breaker) | 45A / 3-pole or 80
A /2-pole (with AC)
or
45A / 3-pole or 70A
/2-pole (w/o AC) | 35 A / 3-pole or 60
A / 2-pole (with AC)
30A / 3-pole or
50A/ 2-pole (w/o
AC) | 70A / 3-pole 3Ø or
100A / 2-pole 2Ø | N/A | Similar, the
overcurrent protection
is less with the
proposed device due
to the use of LED
technology for facials
and different lamps.
The irradiance
Characteristics are still
comparable as
provided under section
18. | N/A | |
| Number of
wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | N/A | Identical | N/A | |
| Irradiance ratio
in accordance
with 1040.20 | fulfilled | fulfilled | fulfilled | N/A | Identical (refer to
section 18 for bench
test reports) | N/A | |
| Parameter | Proposed device | Proposed device | Predicate device 1 | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced | |
| | | | | | | device | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | N/A | Identical | N/A | |
| Electromagnetic compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Identical | N/A | |
11
12
13
14
15
1.2.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.2.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 42-3 Total Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.3 Device trade names of bundle 2:
Planet Fitness 42/3 PLT by Ergoline Ergoline Vitality Pure Light
Common name: Sunlamp product
The following table presents the different variants of the JK 164 / 42-3 Pure Light Technology sunlamp product.
All variants use the same basic device technology and differ only in private labelling, exterior design, decor lighting and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 42-3 PLT AC | Planet Fitness 42/3 PLT by Ergoline |
| JK 164 / 42-3 PLT | Ergoline Vitality Pure Light |
1.3.1 Device description:
Pure Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
16
1.3.2 Legally marketed predicate device 2:
| Device Name: | Planet Fitness 42/4 |
|---|---|
| 510k number: | K151400 CV344_PF_100003421_V01 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
Device Class:
Class II
17
1.3.3 Comparison bundle 2 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate and the proposed device.
| Parameter | Proposed device | Predicate device | Evaluation to predicate device | |
|---|---|---|---|---|
| Model-No. | JK 164 / 42-3 PLT AC | |||
| JK 164 / 42-3 PLT | JK 126 / 42-4 | N/A | ||
| Intended Use | This sunlamp product is intended | |||
| exclusively for aesthetic tanning of | ||||
| the human skin, for one person at a | ||||
| time, at the age of 18 or above | This sunlamp product is intended | |||
| exclusively for aesthetic tanning of | ||||
| the human skin, for one person at a | ||||
| time, at the age of 18 or above | Identical | |||
| Number of body lamps | 42 UV lamps | 42 UV lamps | Identical | |
| Watts of body lamps | 160W | 200 W | Similar, the irradiance characteristics | |
| are still comparable as provided | ||||
| under section 18. | ||||
| In terms of functionality and safety | ||||
| there is no impact due to this | ||||
| difference. | ||||
| Lamp item description | GENESIS PLT Pure Light | |||
| Technology 160W | GENESIS VHP12 | |||
| Dynamic Power 200W | Different description, no impact, see | |||
| above. | ||||
| UV- | ||||
| Facials | Number of UV-facials | 3 x 42 UVA-LED | 4 high pressure lamps | Similar, the irradiance characteristics |
| are still comparable as provided | ||||
| under section 18. | ||||
| In terms of functionality and safety | ||||
| there is no impact due to this | ||||
| difference. | ||||
| Watts facial lamp | 3 x 80W | 4 x 400W | No impact, see below. | |
| Facial item description | Spectra UV-LED | High pressure lamp | ||
| Ergoline Ultra 520W | Similar, the irradiance characteristics | |||
| are still comparable as provided | ||||
| under section 18. | ||||
| In terms of functionality and safety | ||||
| there is no impact due to this | ||||
| difference. | ||||
| Parameter | Proposed device | Predicate device | Evaluation to predicate device | |
| UV-Facials | Filter facial lamps | N/A | Ultra Performance 862 | No filters necessary due to no use of |
| high-pressure lamps. | ||||
| Number of low pressure | ||||
| facial lamps | 2 x PLT | 3 x Type U | Similar, the irradiance characteristics | |
| are still comparable as provided | ||||
| under section 18. | ||||
| In terms of functionality and safety | ||||
| there is no impact due to this | ||||
| difference. | ||||
| Watts low pressure facial | ||||
| lamp | 8W | 8W | Identical | |
| Low pressure facial lamps | ||||
| item description | GENESIS PLT Pure Light | |||
| Technology 8W | Genesis VHP B-Power E9 8W | Different description, no impact, see | ||
| above. | ||||
| Max exposure time [min] | 12 minutes | 12 minutes | Identical | |
| Electrical Requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical | |
| Total power consumption [watts] | 9,000 W (with AC) | |||
| 7,800 W (w/o AC) | 13,200W | Similar, the total power consumption | ||
| is less with the proposed device due | ||||
| to the use of LED technology for | ||||
| facials and different lamps. The | ||||
| irradiance characteristics are still | ||||
| comparable as provided under | ||||
| section 18. | ||||
| Rated overcurrent protection | ||||
| device (circuit breaker) | 35 A / 3-pole or 60 A / 2-pole (with | |||
| AC) | ||||
| 30A / 3-pole or 50A/ 2-pole (w/o | ||||
| AC) | 70A / 3-pole 3Ø or 100A / 2-pole 2Ø | Similar, die overcurrent protection is | ||
| less with the proposed device due to | ||||
| the use of LED technology for facials | ||||
| and different lamps. The irradiance | ||||
| characteristics are still comparable | ||||
| as provided under section 18. | ||||
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical | |
| Irradiance ratio in accordance | ||||
| with 1040.20 | fulfilled | fulfilled | Identical (refer to section 18 for | |
| bench test reports) | ||||
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Identical | |
| Electromagnetic compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
18
19
1.3.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.3.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 42-3 Pure Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.4 Device trade names of bundle 3:
Planet Fitness 50/4 TLT by Ergoline Ergoline Vitality Total Light 3 Planet Fitness 50/4 HLT by Ergoline Ergoline Vitality Hybrid Light 3
Common name: Sunlamp product
The following table presents the different variants of the JK 164 / 50-4 Total Light Technology and JK 164 / 50-4 Hybrid Light Technology sunlamp product.
All variants use the same basic device technology and differ only in private labelling, exterior design, decor lighting, combination of light spectra and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 50-4 TLT-3 TT | Planet Fitness 50/4 TLT by Ergoline |
| JK 164 / 50-4 TLT-3 | Ergoline Vitality Total Light 3 |
| JK 164 / 50-4 HLT-3 TT | Planet Fitness 50/4 HLT by Ergoline |
| JK 164 / 50-4 HLT-3 | Ergoline Vitality Hybrid Light 3 |
| JK 164 / 50-4 TLT TT | Ergoline Vitality Total Light 3 |
| JK 164 / 50-4 TLT AC | Planet Fitness 50/4 TLT by Ergoline |
| JK 164 / 50-4 TLT | Ergoline Vitality Total Light 3 |
1.4.1 Device description:
Total Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
20
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience.
Optimal tanning results are achieved due to the synergistic combination of light spectra.
Hybrid Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results.
Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
1.4.2 Leqally marketed predicate device:
| Device Name: | Ergoline Prestige 1600 Hybrid Technology |
|---|---|
| 510k number: | K180555 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
Legally marketed technical referenced device:
| Device Name: | Sunrise 7200 Hybrid Light Technology |
|---|---|
| 510k number: | K183539 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
21
1.4.3 Comparison bundle 3 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate, the proposed and the technically referenced device.
| Parameter | Proposed
device | Proposed
device | Proposed
device | Proposed
device | Predicate
device | Technically
referenced
device | Evaluation to
predicate
device | Evaluation to
Technically
referenced
device |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Model-No. | JK 164 / 50-4
TLT-3 TT
JK 164 / 50-4
TLT-3 | JK 164 / 50-4
HLT-3 TT
JK 164 / 50-4
HLT-3 | JK 164 /
50-4 TLT
TT | JK 164 /
50-4 TLT
AC
JK 164 /
50-4 TLT | JK 162 / 52-
4 TT HP | JK 158 / 48-
0 HT | N/A | N/A |
| Intended Use | This sunlamp
product is
intended
exclusively for
aesthetic
tanning of the
human skin,
for one
person at a
time, at the
age of 18 or
above | This sunlamp
product is
intended
exclusively for
aesthetic
tanning of the
human skin,
for one person
at a time, at
the age of 18
or above | This
sunlamp
product is
intended
exclusively
for
aesthetic
tanning of
the human
skin, for
one person
at a time,
at the age
of 18 or
above | This
sunlamp
product is
intended
exclusively
for
aesthetic
tanning of
the human
skin, for
one person
at a time,
at the age
of 18 or
above | This
sunlamp
product is
intended
exclusively
for aesthetic
tanning of
the human
skin, for one
person at a
time, at the
age of 18 or
above | N/A | Identical | N/A |
| Parameter | Proposed
device | Proposed
device | Proposed
device | Proposed
device | Predicate
device | Technically
referenced
device | Evaluation to
predicate
device | Evaluation to
Technically
referenced
device |
| Number of body
lamps | 50 (36 UV
lamps + 14
UV+Red Light
lamps) | 50 (36 UV
lamps + 14
UV+Red Light
lamps) | 50 (36 UV
lamps + 14
UV+Red
Light
lamps) | 50 (36 UV
lamps + 14
UV+Red
Light
lamps) | 52 (38 UV
lamps and
14 UV+Red
Light lamps) | N/A | Similar, the
irradiance
characteristics
are still
comparable
as provided
under section
18. The safety
has been
confirmed
additionally by
corresponding
tests in
accordance
with IEC
62471.
In terms of
functionality
and safety
there is no
impact due to
this
difference. | N/A |
| Watts of body
lamps | 200W | 200W | 160W | 160W | 200 W | N/A | Identical | N/A |
| Lamp item
description | GENESIS
PLT Pure
Light
Technology
200W
GENESIS
HLT Hybrid
Light
Technology
200W
(UV&Red
light) | GENESIS PLT
Pure Light
Technology
200W
GENESIS
HLT Hybrid
Light
Technology
200W
(UV&Red
light) | GENESIS
PLT Pure
Light
Technology
160W
GENESIS
HLT Hybrid
Light
Technology
160W
(UV&Red
light) | GENESIS
PLT Pure
Light
Technology
| GENESIS
Type U
Hybrid
Performance
GENESIS
Type R
Hybrid
Performance
(UV & Red
light) | N/A | Different
description,
no impact,
see above. | N/A |
22
23
| Parameter | Proposed device | Proposed device | Proposed device | Proposed device | Predicate device | Technically referenced device | Evaluation to predicate device | Evaluation to Technically referenced device | |
|---|---|---|---|---|---|---|---|---|---|
| Number of Total Light-LED | 108 LED (54 Red + 54 Blue) | 90 Red LED | 36 LED (18 RED + 18 Blue) | 36 LED (18 RED + 18 Blue) | N/A | 60 Red LED | N/A | Similar, the irradiance characteristics are still comparable as provided under section 18. The safety has been confirmed additionally by corresponding tests in accordance with IEC 62471. In terms of functionality and safety there is no impact due to this difference. | |
| Watts of Total Light-LED | 150W | 120W | 50W | 50W | N/A | 45W | N/A | No impact, see below. | |
| Parameter | Proposed device | Proposed device | Proposed device | Proposed device | Predicate device | Technically referenced device | Evaluation to predicate device | Evaluation to Technically referenced device | |
| UV-Facials | Number of UV-facials | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 high pressure lamps | N/A | Similar, the irradiance characteristics are still comparable as provided under section 18. In terms of functionality and safety there is no impact due to this difference. | N/A |
| Watts facial lamp | 4 x 80W | 4 x 80W | 4 x 80W | 4 x 80W | 4 x 520 W | N/A | No impact, see below. | N/A | |
| Facial item description | Spectra UV-LED | Spectra UV-LED | Spectra UV-LED | Spectra UV-LED | High pressure lamp Ergoline Ultra 520W | N/A | Similar, the irradiance characteristics are still comparable as provided under section 18. In terms of functionality and safety there is no impact due to this difference. | N/A | |
| Filter facial lamps | N/A | N/A | N/A | N/A | Ultra Performance 412 | N/A | No filters necessary due to no use of high pressure lamps. | N/A | |
| Parameter | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Predicate | ||||||||
| device | Technically | ||||||||
| referenced | |||||||||
| device | Evaluation to | ||||||||
| predicate | |||||||||
| device | Evaluation to | ||||||||
| Technically | |||||||||
| referenced | |||||||||
| device | |||||||||
| UV-Facials | Number of | ||||||||
| low | |||||||||
| pressure | |||||||||
| facial | |||||||||
| lamps | 4 x HLT | 4 x HLT | 4 x HLT | 4 x HLT | 3 x Type R | N/A | Similar, the | ||
| irradiance | |||||||||
| characteristics | |||||||||
| are still | |||||||||
| comparable as | |||||||||
| provided under | |||||||||
| section 18. The | |||||||||
| safety has been | |||||||||
| confirmed | |||||||||
| additionally by | |||||||||
| corresponding | |||||||||
| tests in | |||||||||
| accordance | |||||||||
| with IEC 62471. | |||||||||
| In terms of | |||||||||
| functionality | |||||||||
| and safety | |||||||||
| there is no | |||||||||
| impact due to | |||||||||
| this difference. | N/A | ||||||||
| Watts low | |||||||||
| pressure | |||||||||
| facial lamp | 8W | 8W | 8W | 8W | 8 W | N/A | Identical | N/A | |
| Low | |||||||||
| pressure | |||||||||
| facial | |||||||||
| lamps item | |||||||||
| description | GENESIS | ||||||||
| HLT Hybrid | |||||||||
| Light | |||||||||
| Technology | |||||||||
| 8W | GENESIS | ||||||||
| HLT Hybrid | |||||||||
| Light | |||||||||
| Technology | |||||||||
| 8W | GENESIS | ||||||||
| HLT Hybrid | |||||||||
| Light | |||||||||
| Technology | |||||||||
| 8W | GENESIS | ||||||||
| HLT Hybrid | |||||||||
| Light | |||||||||
| Technology | |||||||||
| 8W | Genesis | ||||||||
| Type R | |||||||||
| Hybrid 8W | N/A | Different | |||||||
| description, no | |||||||||
| impact, see | |||||||||
| above. | N/A | ||||||||
| Parameter | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Predicate | ||||||||
| device | Technically | ||||||||
| referenced | |||||||||
| device | Evaluation to | ||||||||
| predicate | |||||||||
| device | Evaluation | ||||||||
| to | |||||||||
| Technically | |||||||||
| referenced | |||||||||
| device | |||||||||
| Shoulder Tanner | Number of | ||||||||
| Shoulder | |||||||||
| lamps | 2 x 20 UVA- | ||||||||
| LED | 2 x 20 UVA- | ||||||||
| LED | 2 x 20 | ||||||||
| UVA-LED | 2 x 20 | ||||||||
| UVA-LED | 2 high | ||||||||
| pressure | |||||||||
| lamps | N/A | Similar, the | |||||||
| irradiance | |||||||||
| characteristics | |||||||||
| are still | |||||||||
| comparable as | |||||||||
| provided under | |||||||||
| section 18. | |||||||||
| In terms of | |||||||||
| functionality and | |||||||||
| safety there is | |||||||||
| no impact due to | |||||||||
| this difference. | N/A | ||||||||
| Watts of | |||||||||
| shoulder | |||||||||
| lamps | 2 x 40W | 2 x 40W | 2 x 40W | 2 x 40W | 240W | N/A | No impact, see | ||
| below. | N/A | ||||||||
| Lamp item | |||||||||
| description | |||||||||
| shoulder | |||||||||
| lamps | Spectra UV- | ||||||||
| LED | Spectra UV- | ||||||||
| LED | Spectra | ||||||||
| UV-LED | Spectra | ||||||||
| UV-LED | Ergoline | ||||||||
| Ultra 250W | N/A | Similar, the | |||||||
| irradiance | |||||||||
| characteristics | |||||||||
| are still | |||||||||
| comparable as | |||||||||
| provided under | |||||||||
| section 18. | |||||||||
| In terms of | |||||||||
| functionality and | |||||||||
| safety there is | |||||||||
| no impact due to | |||||||||
| this difference. | N/A | ||||||||
| Filter | |||||||||
| shoulder | |||||||||
| lamps | N/A | N/A | N/A | N/A | Ultra | ||||
| Performance | |||||||||
| 912 | N/A | No filters | |||||||
| necessary due | |||||||||
| to no use of | |||||||||
| high pressure | |||||||||
| lamps. | N/A | ||||||||
| Parameter | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Proposed | ||||||||
| device | Predicate | ||||||||
| device | Technically | ||||||||
| referenced | |||||||||
| device | Evaluation to | ||||||||
| predicate | |||||||||
| device | Evaluation | ||||||||
| to | |||||||||
| Technically | |||||||||
| referenced | |||||||||
| device | |||||||||
| Max exposure time | |||||||||
| [min] | 10 minutes | 10 minutes | 10 minutes | 10 | |||||
| minutes | 10 minutes | N/A | Identical | N/A | |||||
| Electrical | |||||||||
| Requirements | 230V 3Ø or | ||||||||
| 230V 2Ø | 230V 3Ø or | ||||||||
| 230V 2Ø | 230V 3Ø or | ||||||||
| 230V 2Ø | 230V 3Ø | ||||||||
| or 230V | |||||||||
| 2Ø | 230V 3Ø or | ||||||||
| 230V 2Ø | N/A | Identical | N/A | ||||||
| Total power | |||||||||
| consumption | |||||||||
| [watts] | 14,600 W (w | ||||||||
| TT) | |||||||||
| 12,200 W | |||||||||
| (w/o TT) | 14,600 W (w | ||||||||
| TT) | |||||||||
| 12,200 W (w/o | |||||||||
| TT) | 11,400 W | ||||||||
| (w TT) | 10,200 W | ||||||||
| (with AC) | |||||||||
| 9,000 W | |||||||||
| (w/o AC) | 17,600W | N/A | Similar, the | ||||||
| total power | |||||||||
| consumption is | |||||||||
| less with the | |||||||||
| proposed | |||||||||
| device due to | |||||||||
| the use of LED | |||||||||
| technology for | |||||||||
| facials and less | |||||||||
| lamps. The | |||||||||
| irradiance | |||||||||
| characteristics | |||||||||
| are still | |||||||||
| comparable as | |||||||||
| provided | |||||||||
| under section |
- | N/A | |
| Parameter | Proposed
device | Proposed
device | Proposed
device | Proposed
device | Predicate
device | Technically
referenced
device | Evaluation to
predicate
device | Evaluation
to
Technically
referenced
device | |
| Rated overcurrent
protection device
(circuit breaker) | 60A / 3-pole
or 90 A /2-
pole (with
TT) or
50A / 3-pole
or 80 A/2-
pole (w/o TT) | 60A / 3-pole or
90A /2-pole
(with TT) or
50A / 3-pole or
80A /2-pole
(w/o TT) | 40A /3-pole
or 70A / 2-
pole (with
TT) | 40A /3-
pole or 70
A/2-pole
(with AC)
or
40A / 3-
pole or 60
A/ 2-pole
(w/o AC) | 70A / 3-pole
3Ø or 100A /
2-pole 2Ø | N/A | Similar, die
overcurrent
protection is
less with the
proposed
device due to
the use of LED
technology for
facials and less
lamps. The
irradiance
characteristics
are still
comparable as
provided
under section - | N/A | |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | N/A | Identical | N/A | |
| Irradiance ratio in
accordance with
1040.20 | fulfilled | fulfilled | fulfilled | fulfilled | fulfilled | N/A | Identical (refer
to section 18 for
bench test
reports) | N/A | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | N/A | Identical | N/A | |
| Electromagnetic
compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Identical | N/A | |
24
25
26
27
28
29
1.4.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.4.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 50-4 Total Light Technology and JK 164 / 50-4 Hybrid Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.5 Device trade names of bundle 4:
Planet Fitness 50/4 PLT III by Ergoline Ergoline Vitality Pure Light 3 Planet Fitness 50/4 PLT by Ergoline Ergoline Vitality Pure Light
Sunlamp product Common name:
The following table presents the different variants of the JK 164 / 50-4 Pure Light Technology sunlamp product.
All variants use the same basic device technology and differ only private labelling, exterior design, decor lighting and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 50-4 PLT-3 AC | Planet Fitness 50/4 PLT III by Ergoline |
| JK 164 / 50-4 PLT-3 | Ergoline Vitality Pure Light 3 |
| JK 164 / 50-4 PLT AC | Planet Fitness 50/4 PLT by Ergoline |
| JK 164 / 50-4 PLT | Ergoline Vitality Pure Light |
30
1.5.1 Device description:
Pure Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
1.5.2 Legally marketed predicate device 4:
| Device Name: | Affinity 900 AP TT AM/A USA |
|---|---|
| 510k number: | K151400 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
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1.5.3 Comparison bundle 4 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate and the proposed device.
| Parameter | Proposed device | Proposed device | Predicate device | Evaluation to predicate device | |
|---|---|---|---|---|---|
| Model-No. | JK 164 / 50-4 PLT-3 AC | ||||
| JK 164 / 50-4 PLT-3 | JK 164 / 50-4 PLT AC | ||||
| JK 164 / 50-4 PLT | JK 155 / 50-4 TT | N/A | |||
| Intended Use | This sunlamp product is | ||||
| intended exclusively for | |||||
| aesthetic tanning of the | |||||
| human skin, for one | |||||
| person at a time, at the | |||||
| age of 18 or above | This sunlamp product is | ||||
| intended exclusively for | |||||
| aesthetic tanning of the | |||||
| human skin, for one | |||||
| person at a time, at the | |||||
| age of 18 or above | This sunlamp product is | ||||
| intended exclusively for | |||||
| aesthetic tanning of the | |||||
| human skin, for one | |||||
| person at a time, at the | |||||
| age of 18 or above | Identical | ||||
| Number of body lamps | 50 UV lamps | 50 UV lamps | 50 UV lamps | Identical | |
| Watts of body lamps | 200W | 160W | 160 W | Similar, the irradiance | |
| characteristics are still | |||||
| comparable as provided | |||||
| under section 18. | |||||
| In terms of functionality | |||||
| and safety there is no | |||||
| impact due to this | |||||
| difference. | |||||
| Lamp item description | GENESIS PLT Pure Light | ||||
| Technology 200W | GENESIS PLT Pure Light | ||||
| Technology 160W | GENESIS VHP12 160W | Different description, no | |||
| impact, see above. | |||||
| UV-Facials | Number of UV- | ||||
| facials | 4 x 42 UVA-LED | 4 x 42 UVA-LED | 4 high pressure lamps | Similar, the irradiance | |
| characteristics are still | |||||
| comparable as provided | |||||
| under section 18. | |||||
| In terms of functionality | |||||
| and safety there is no | |||||
| impact due to this | |||||
| difference. | |||||
| Watts facial lamp | 4 x 80W | 4 x 80W | 4 x 520 W | No impact, see below. | |
| Parameter | Proposed device | Proposed device | Predicate device | Evaluation to predicate | |
| device | |||||
| UV-Facials | Facial item | ||||
| description | Spectra UV-LED | Spectra UV-LED | High pressure lamp | ||
| Ergoline Ultra 520W | Similar, the irradiance | ||||
| characteristics are still | |||||
| comparable as provided | |||||
| under section 18. | |||||
| In terms of functionality | |||||
| and safety there is no | |||||
| impact due to this | |||||
| difference. | |||||
| Filter facial lamps | N/A | N/A | Ultra Performance 412H | No filters necessary due | |
| to no use of high | |||||
| pressure lamps. | |||||
| Number of low | |||||
| pressure facial | |||||
| lamps | 4 x PLT | 4 x PLT | 3 x Type U | Similar, the irradiance | |
| characteristics are still | |||||
| comparable as provided | |||||
| under section 18. | |||||
| In terms of functionality | |||||
| and safety there is no | |||||
| impact due to this | |||||
| difference. | |||||
| Watts low | |||||
| pressure facial | |||||
| lamp | 8W | 8W | 8 W | Identical | |
| Low pressure | |||||
| facial lamps item | |||||
| description | GENESIS PLT Pure Light | ||||
| Technology 8W | GENESIS PLT Pure Light | ||||
| Technology 8W | GENESIS VHP12 8W | Different description, no | |||
| impact, see above. | |||||
| Shoulder Tanner | Number of | ||||
| Shoulder lamps | 2 x 20 UVA-LED | 2 x 20 UVA-LED | 7 low pressure lamps | Similar, the irradiance | |
| characteristics are still | |||||
| comparable as provided | |||||
| under section 18. | |||||
| In terms of functionality | |||||
| and safety there is no | |||||
| impact due to this | |||||
| difference. | |||||
| Watts of shoulder | |||||
| lamps | 2 x 40W | 2 x 40W | 7 x 25W | No impact, see below. | |
| Parameter | Proposed device | Proposed device | Predicate device | Evaluation to predicate | |
| device | |||||
| Shoulder Tanner | Lamp item description | ||||
| shoulder lamps | Spectra UV-LED | Spectra UV-LED | GENESIS VHP12 25 W | Similar, the irradiance | |
| characteristics are still | |||||
| comparable as provided | |||||
| under section 18. | |||||
| In terms of functionality | |||||
| and safety there is no | |||||
| impact due to this | |||||
| difference. | |||||
| Filter shoulder | |||||
| lamps | N/A | N/A | N/A | No filters necessary due | |
| to no use of high | |||||
| pressure lamps. | |||||
| Max exposure time [min] | 12 minutes | 12 minutes | 12 minutes | Identical | |
| Electrical Requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical | |
| Total power consumption | |||||
| [watts] | 13,400 W (w AC) | ||||
| 12,200 W (w/o AC) | 10,600 W (w AC) | ||||
| 9,400 W (w/o AC) | 17,000W | Similar, the total power | |||
| consumption is less with | |||||
| the proposed device due | |||||
| to the use of LED | |||||
| technology for facials. The | |||||
| irradiance characteristics | |||||
| are still comparable as | |||||
| provided under section |
- |
| | Rated overcurrent
protection device
(circuit breaker) | 50A / 3-pole or 90 A /2-
pole (with AC) or
50A / 3-pole or 80 A /2-
pole (w/o AC) | 40A / 3-pole or 70 A /2-
pole (with AC) or
40A / 3-pole or 60A /2-
pole (w/o AC) | 60A / 3-pole 3Ø or 110A /
2-pole 2Ø | Similar, die overcurrent
protection is less with the
proposed device due to
the use of LED
technology for facials. The
irradiance characteristics
are still comparable as
provided under section - |
| | Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical |
| | Irradiance ratio in
accordance with 1040.20 | fulfilled | fulfilled | fulfilled | Identical (refer to section
18 for bench test reports) |
| | Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | Identical |
| | Electromagnetic
compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
32
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34
1.5.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.5.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 50-4 Pure Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
1.6 Device trade names of bundle 5:
Planet Fitness 46/3 PLT by Ergoline Ergoline Vitality Pure Light Planet Fitness 46/3 HLT by Ergoline Ergoline Vitality Hybrid Light
Sunlamp product Common name:
The following table presents the different variants of the JK 164 / 46-3 Pure Light Technology and JK 164 / 46-3 Hybrid Light Technology sunlamp product.
All variants use the same basic device technology and differ only private labelling, exterior design, decor lighting, combination of light spectra and comfort features.
| Model-No. | Variant Name |
|---|---|
| JK 164 / 46-3 PLT AC | |
| JK 164 / 46-3 PLT | Planet Fitness 46/3 PLT by Ergoline |
| Ergoline Vitality Pure Light | |
| JK 164 / 46-3 HLT AC | |
| JK 164 / 46-3 HLT | Planet Fitness 46/3 HLT by Ergoline |
| Ergoline Vitality Hybrid Light |
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1.6.1 Device Description:
Pure Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
Hybrid Light Technology
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
1.6.2 Legally marketed predicate device 5:
| Device Name: | Affinity 700 PF AP AC USA |
|---|---|
| 510k number: | K151400 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
36
1.6.3 Comparison bundle 5 to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate and the proposed device.
| Parameter | Proposed device | Proposed device | Predicate device | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model-No. | JK 164 / 46-3 PLT
AC
JK 164 / 46-3 PLT | JK 164 / 46-3 HLT
AC
JK 164 / 46-3 HLT | JK 155 / 46-3 | JK 158 / 48-
0 HT | N/A | N/A | |
| Intended Use | This sunlamp
product is intended
exclusively for
aesthetic tanning of
the human skin, for
one person at a time,
at the age of 18 or
above | This sunlamp
product is intended
exclusively for
aesthetic tanning of
the human skin, for
one person at a
time, at the age of
18 or above | This sunlamp
product is intended
exclusively for
aesthetic tanning of
the human skin, for
one person at a
time, at the age of
18 or above | N/A | Identical | N/A | |
| Number of body lamps | 46 UV lamps | 46 UV lamps | 46 UV lamps | N/A | Identical | N/A | |
| Watts of body lamps | 160W | 160W | 160W | N/A | Identical | N/A | |
| Lamp item description | GENESIS PLT Pure
Light Technology
160W | GENESIS PLT
Pure Light
Technology 160W | GENESIS VHP12
160W | N/A | Different description,
no impact, see above. | N/A | |
| Parameter | | Proposed device | Proposed device | Predicate device | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device |
| | Number of Total Light-LED | N/A | 72 Red LED | N/A | 60 Red LED | N/A | Similar, the
irradiance
characteristics
are still
comparable as
provided under
section 18. The
safety has been
confirmed
additionally by
corresponding
tests in
accordance with
IEC 62471.
In terms of
functionality and
safety there is
no impact due to
this difference. |
| | Watts of Total Light-LED | N/A | 95W | N/A | 45W | N/A | No impact, see
below. |
| UV-Facials | Number of
UV-facials | 3 x 42 UVA-LED | 3 x 42 UVA-LED | 3 high pressure
lamps | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18.
In terms of
functionality and
safety there is no
impact due to this
difference. | N/A |
| | Watts facial
lamp | 3 x 80W | 3 x 80W | 3 x 500W | N/A | No impact, see below. | N/A |
| Parameter | Proposed device | Proposed device | Predicate device | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
| UV-Facials | Facial item
description | Spectra UV-LED | Spectra UV-LED | High pressure lamp
Ergoline Ultra
520W | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18.
In terms of
functionality and
safety there is no
impact due to this
difference. | N/A |
| | Filter facial
lamps | N/A | N/A | Ultra Performance
412 H | N/A | No filters necessary
due to no use of high
pressure lamps. | N/A |
| | Number of low
pressure facial
lamps | 2x PLT | 2x HLT | 2 x Type U | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18. The safety has
been confirmed
additionally by
corresponding tests in
accordance with IEC
62471.
In terms of
functionality and
safety there is no
impact due to this
difference. | N/A |
| | Watts low
pressure facial
lamp | 8W | 8W | 8W | N/A | Identical | N/A |
| | Low pressure
facial lamps
item
description | GENESIS PLT Pure
Light Technology 8W | GENESIS HLT
Hybrid Light
Technology 8W | GENESIS VHP12
8W | N/A | Different description,
no impact, see above. | N/A |
| Parameter | Proposed device | Proposed device | Predicate device | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
| Shoulder Tanner | Number of
Shoulder
lamps | 2 x 20 UVA-LED | 2 x 20 UVA-LED | 7 low pressure
lamps | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18.
In terms of
functionality and
safety there is no
impact due to this
difference. | N/A |
| | Watts of
shoulder
lamps | 2 x 40W | 2 x 40W | 7 x 25W | N/A | No impact, see below. | N/A |
| | Lamp item
description
shoulder
lamps | Spectra UV-LED | Spectra UV-LED | GENESIS VHP12
25 W | N/A | Similar, the irradiance
characteristics are still
comparable as
provided under section
18.
In terms of
functionality and
safety there is no
impact due to this
difference. | N/A |
| | Filter shoulder
lamps | N/A | N/A | N/A | N/A | No filters necessary
due to no use of high
pressure lamps. | N/A |
| Max exposure time
[min] | | 12 minutes | 12 minutes | 12 minutes | N/A | Identical | N/A |
| Electrical
Requirements | | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V
2Ø | 230V 3Ø or 230V
2Ø | N/A | Identical | N/A |
| Parameter | Proposed device | Proposed device | Predicate device | Technically
referenced
device | Evaluation to
predicate device | Evaluation to
Technically
referenced
device | |
| Total power
consumption [watts] | 9,600 W (with AC)
8,400 W (w/o AC) | 9,600 W (with
AC)
8,400 W (w/o AC) | 13,700W | N/A | Similar, the total
power consumption
is less with the pro-
posed device due to
the use of LED tech-
nology for facials.
The irradiance cha-
racteristics are still
comparable as
provided under
section 18. | N/A | |
| Rated overcurrent
protection device
(circuit breaker) | 40A / 3-pole or 60A
/ 2-pole (with AC)
or
35A /3-pole or 60A
/ 2-pole (w/o AC) | 40A / 3-pole or
60A / 2-pole (with
AC) or
35A /3-pole or
60A / 2-pole (w/o
AC) | 50A / 3-pole 3Ø or
80A / 2-pole 2Ø | N/A | Similar, die overcur-
rent protection is
less with the propo-
sed device due to
the use of LED tech-
nology for facials.
The irradiance
characteristics are
still comparable as
provided under
section 18. | N/A | |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | N/A | Identical | N/A | |
| Irradiance ratio in
accordance with
1040.20 | fulfilled | fulfilled | fulfilled | N/A | Identical (refer to
section 18 for bench
test reports) | N/A | |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | N/A | Identical | N/A | |
| Electromagnetic
compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Identical | N/A | |
37
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39
40
41
1.6.4 Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20.
1.6.5 Conclusion:
JK-Holding GmbH believes that the JK 164 / 46-3 Pure Light Technology and JK 164 / 46-3 Hybrid Light Technology are substantially equivalent to currently legally marketed devices. Also, all special controls are fulfilled. These devices do not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.