(109 days)
Not Found
No
The document describes a sunlamp product that uses UV and red light for tanning. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The "Intended Use / Indications for Use" states that the device is "exclusively for aesthetic tanning of the human skin," which is not a therapeutic purpose.
No
The device is described as a "sunlamp product" intended for "aesthetic tanning of the human skin," which is a cosmetic purpose, not a diagnostic one. No mention of diagnosis, disease detection, or medical assessment is made.
No
The device description explicitly states the primary technical components are "artificial sources of UV radiation as well as a mechanical structure," indicating it is a hardware device that emits UV light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "exclusively for aestetic tanning of the human skin." This is a cosmetic or aesthetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description focuses on the technical components related to UV radiation and its effect on skin tanning. It does not mention any components or processes related to analyzing biological samples.
- Lack of Diagnostic Information: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances to provide diagnostic information.
In summary, the device's purpose is to alter the appearance of the skin through tanning, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
This sunlamp product is intended exclusively for aestetic tanning of the human skin, for one person at a time, at the age of 18 or above.
Product codes (comma separated list FDA assigned to the subject device)
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. UV-B radiation is primarily responsible for more long-term tanning results.
The Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology provides tanning results by combining traditional UV light with red light in a 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
JK-Holding GmbH Juergen Gerstenmeier Executive Director Research & Development Koehlershohner Strabe 60 Windhagen, 53578 DE
April 8, 2019
Re: K183539
Trade/Device Name: Ergoline Sunrise 7200 Hybrid Technology 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: March 5, 2019 Received: March 7, 2019
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183539
Device Name Ergoline Sunrise 7200 Hybrid Technology
Indications for Use (Describe)
This sunlamp product is intended exclusively for aestetic 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
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 for the Ergoline Sunrise 7200 Hybrid Technology and their further private label sunlamp products meets the requirements of 21 CFR 807.92
| Submitter information: | JK-HOLDING GmbH
Koehlershohner Strasse 60
53578 Windhagen
Germany
Phone: +49 (0) 2224 / 818-0
Fax: +49 (0) 2224 / 818-116 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Facility: | JK-Products GmbH
Rottbitzer Strasse 69
53604 Bad Honnef
Germany
Establishment Registration Number: 9615023
Owner/Operator Number: 9034303 |
| Official Correspondent: | Juergen Gerstenmeier
Koehlershohner Strasse 60
53578 Windhagen
Germany
Phone: +49 (0) 2224 / 818-330
Email: juergen.gerstenmeier@de.jk-group.net |
| US Agent (Contact): | Kevin Hart
JK PRODUCTS & SERVICES, INC.
411 West Washington Ave Suite B
Jonesboro, AR 72401
Phone: 870-2682862
Fax: 870 9359046
Email: Kevin.Hart@Jkamerica.com |
| Date Prepared: | April 8th, 2019 |
5
Device(s) Identification:
| Device trade name: | Ergoline Sunrise 7200 Hybrid Technology |
|---|---|
| Common name: | Sunlamp product |
The following table presents the different variants of the Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology sunlamp product.
All variants use the same basic device technology and differ only in effect lighting, comfort features and private labelling. All variants use the hybrid light technology.
| Model-No.: | Variant Name: |
|---|---|
| JK 158 / 48-0 HT | Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness Sound/ |
| Bluetooth | |
| JK 158 / 48-0 HT VS | Ergoline Sunrise 7200 Hybrid Light Technology Planet Fitness Sound / |
| Bluetooth / Vibra Shape | |
| JK 158 / 48-0 HT | Ergoline Sunrise 7200 Hybrid Technology / Sound/ Bluetooth |
| JK 158 / 48-0 HT VS | Ergoline Sunrise 7200 Hybrid Technology Sound / Bluetooth / Vibra Shape |
The basic products can be upgraded with conversion kits, consisting of stickers with the private label naming, to Soltron, Palm Beach Tan or further private label sunlamp products, The conversion kit only serves to label the basic product as a Soltron, Palm Beach Tan or further private label sunlamp product. It does not alter any technical specification or aspect of the devices.
Classification of the 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 |
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. UV-B radiation is primarily responsible for more long-term tanning results.
The Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology provides tanning results by combining traditional UV light with red light in a synergistic combination of light spectra.
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.
6
Legally Marketed Predicate device:
| Device Name: | Sunrise 6200 and Sunrise 7200 |
|---|---|
| Model No.: | JK 158 / 48-0 and JK 158 / 48-0 VS |
| 510k number: | K173565 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
Comparison to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed devices.
| Parameter | Proposed device
JK 158 / 48-0 HT
JK 158 / 48-0 HT VS | Predicate device
JK 158 / 48-0
JK 158 / 48-0 VS | Evaluation |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | This sunlamp product
is intended
exclusively for
cosmetic tanning of
the human skin, for
one person at a time,
at the age of 18 or
above. | Identical |
| Number of body lamps | 48 (34 UV lamps and
14 UV+Red Light
lamps) | 48 (all UV lamps) | Similar:
The irradiance
characteristics are
comparable. 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 | 200 | 200 | Identical |
| Parameter | Proposed device
JK 158 / 48-0 HT
JK 158 / 48-0 HT VS | Predicate device
JK 158 / 48-0
JK 158 / 48-0 VS | Evaluation |
| Lamp item description | GENESIS Type U
Hybrid Performance -
200 W
(UV light) and
GENESIS Type R
Hybrid Performance -
200 W
(Mix of UV+Red Light) | GENESIS VHP9
Smart Performance
200 W | Similar:
The irradiance
characteristics are
comparable. 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 |
| Number of Beauty Light
LEDs | 60 (3x20) | none | The irradiance
characteristics are
comparable. 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 | 45 (3x15) | none | No impact (see above) |
| Max exposure time
[min] | 9 | 9 | Identical |
| Electrical requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical |
| Total power
consumption [Watts] | 10600 | 9500 | Similar:
The power is higher
due to the use of
different electronic
lamp ballasts.
Performance is not
impaired. |
| Parameter | Proposed device
JK 158 / 48-0 HT
JK 158 / 48-0 HT VS | Predicate device
JK 158 / 48-0
JK 158 / 48-0 VS | Evaluation |
| Rated overcurrent
protection device
(circuit breaker) | 40A / 3-pole 3Ø or
70A / 2-pole 2Ø | 40A / 3-pole 3Ø or
70A / 2-pole 2Ø | identical. |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | identical |
| Irradiance ratio in
accordance with
1040.20 | fulfilled | fulfilled | identical |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | identical |
| Electromagnetic
compatibility | IEC 60601-1-2 | IEC 60601-1-2 | identical |
7
8
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
Conclusion:
JK Holding GmbH believes that the proposed devices are substantially equivalent to the legally marketed predicate device. Also, all Special Controls are fulfilled. The proposed devices do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.