(113 days)
Not Found
Not Found
No
The document describes a standard sunlamp product with UV radiation sources and a mechanical structure. There is no mention of AI, ML, image processing, or any data-driven algorithms for analysis or control. The performance studies focus on safety and spectral emission, not algorithmic performance.
No
The device is described as being for "cosmetic tanning of the human skin," which is not a therapeutic purpose.
No
Explanation: The device is a sunlamp product intended exclusively for cosmetic tanning of human skin. Its function is to produce UV radiation for tanning, not to diagnose any medical condition.
No
The device description explicitly states the primary technical components are artificial sources of UV radiation and a mechanical structure, indicating a hardware-based device.
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 cosmetic tanning of the human skin." This is a cosmetic purpose, not a diagnostic one.
- Device Description: The device description focuses on the technical components related to UV radiation for tanning, not on analyzing samples from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
The device is clearly described as a sunlamp product for cosmetic tanning, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
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 and a mechanical structure.
Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
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 longterm tanning results.
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 (IEC 60335-2-27 and UL482) and EMC in accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2).
The spectral emission of all sunlamp products was measured. The test procedure for measuring the spectral emission is in accordance with IEC 60335-2-27.
The irradiance ratio limits of all proposed sunlamp products are in accordance with 21 CFR 1040.20 (c) (1). The maximum timer intervals and exposure schedules have been determined according to FDA's "policy on maximum timer interval and exposure schedule for sunlamp products"
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.
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, layered on top of each other. The profiles are connected by a curved line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
JK HOLDING GmbH Juergen Gerstenmeier Official Correspondent Koehlershohner Strasse 60 53578 Windhagen Germany
Re: K151400
Trade/Device Name: Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: August 14, 2015 Received: August 18, 2015
Dear 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. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151400
Device Name
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
Indications for Use (Describe)
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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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, Soltron, Sun Angel, Sundash and Palm Beach Tan private label sunlamp products meets the requirements of 21 CFR 807.92
| Submitter information: | JK HOLDING GmbH
Koehlershohner Strasse 60
53578 Windhagen
Phone: +49 (0) 2224 / 818-0
Fax: +49 (0) 2224 / 818-116 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 9615023
Owner/Operator Number: 9034303 |
| Official Correspondent (Contact): | Jürgen Gerstenmeier
Koehlershohner Strasse 60
53578 Windhagen
Germany
Phone: +49 (0) 2224 / 818-330
Email: juergen.gerstenmeier@de.jk-group.net |
| US Agent: | Lateef Khan
JK PRODUCTS & SERVICES, Inc.
#1 Walter Kratz Drive
Jonesboro, AR 72401
Phone: 870-2682700
Fax: 870-9359046
E-Mail: Ikhan@jkamerica.com |
Date Prepared:
August 12th, 2015
4
Device(s) Identification:
| Device trade name: | Ergoline sunlamp products |
|---|---|
| Common name: | Ergoline sunlamp products |
The following table presents the Ergoline sunlamp products in comparison to Soltron private label devices.
The basic products can be upgraded with the conversion kit to Soltron private label sunlamp products.
The Ergoline, Soltron, Sun Angel, Sundash or Palm Beach Tan private label sunlamp products contain the same basic products, which are the technical fundament for different product lines. The conversion kit only serves to label the basic product as a Soltron or Palm Beach Tan private label sunlamp product. It does not alter any technical specification or aspect of the devices.
| Model-No.: | Ergoline sunlamp products: | Conversion Kit /
Private Label: |
|---------------------|-------------------------------------------------------------|------------------------------------|
| JK 103 / 34-3 | Ergoline/PASSION 34/3 Super Power | XS-40 KISS |
| JK 103 / 40-3 | Ergoline/PASSION 40/3 Turbo Power
(WHITE) | S-45 FLIRT |
| JK 103 / 40-3 | Ergoline/PASSION 40/3 Turbo Power
(BLACK) | S-45 FLIRT |
| JK 103 / 40-3 AC | Ergoline/PASSION PLUS 40/3 Turbo Power
(WHITE) | S-45 FLIRT+AC |
| JK 103 / 40-3 AC | Ergoline/PASSION PLUS 40/3 Turbo Power
(BLACK) | S-45 FLIRT+AC |
| JK 98 / 48-0 | Ergoline/SUNRISE 480 Turbo Power | V-55 UNIVERSE |
| JK 98 / 48-0 | Ergoline/SUNRISE 480 Turbo Power
(Sound & Ambient Light) | V-55 UNIVERSE |
| JK 70 / 0-30 | Ergoline/ Open Sun 1050 | XXL-95 SHARK |
| JK 155 / 46-3 AC | Ergoline/AFFINITY 700 Advanced Performance | L-70 BUTTERFLY |
| JK 155 / 46-3 | Ergoline/AFFINITY 700 Advanced Performance | L-70 BUTTERFLY |
| JK 155 / 50-4 TT | Ergoline/AFFINITY 900 Advanced Performance | XL-85 WILDCAT |
| JK 116 / 48-0 | Ergoline/ ESSENCE 48 SMART POWER
(Grey) | V-50 SPACE CAB |
| JK 127 / 48-4 TT | Ergoline/Prestige 1000 Intelligent Performance | XXL-115 STARLIGHT |
| JK 127 / 52-4 TT | Ergoline/Prestige 1400 Intelligent Performance | XXL-125 EAGLE |
| JK 126 / 38-3 AC | Ergoline/Inspiration 500 Smart Performance | M-55 RACER |
| JK 126 / 42-4 AC | Ergoline/Inspiration 600 Dynamic Performance | M-60 JUMP |
| JK 92 / 43-3 | Ergoline/AFFINITY 500 Turbo Power | - |
| JK 92 / 46-3-AC | Ergoline/AFFINITY 600 Turbo Power
Air Condition | - |
| JK 92 / 51-4 TT | Ergoline/AFFINITY 800 Turbo Power
Temptronic | - |
| JK 116 / 48-0 | Ergoline/ ESSENCE 48 SMART POWER
(Red) | - |
| JK 116 / 48-0 | Ergoline/ ESSENCE 48 SMART POWER
(PBT) | - |
| JK 127 / SS 48-4-TT | Ergoline/Sun Select 1000 Intelligent Performance | - |
5
| Model-No.: | Ergoline sunlamp products: | Conversion Kit /
Private Label: |
|---------------------|--------------------------------------------------|------------------------------------|
| JK 127 / SS 52-4 TT | Ergoline/Sun Select 1400 Intelligent Performance | - |
| JK 103 / 34-0 | Ergoline / Passion 34 Super Power
(20 min) | - |
| JK 103 / 34-0 | Ergoline / Passion 34 Super Power
(15 min) | - |
| JK 103 / 32-0 | Ergoline/ Flair 32 Super Power
(20 min) | - |
| JK 103 / 32-0 | Ergoline/ Flair 32 Super Power
(15 min) | - |
| JK 103 / 32-1 | Ergoline/ Flair 32/1 Super Power
(20 min) | - |
| JK 103 / 32-1 | Ergoline/ Flair 32/1 Super Power
(15 min) | - |
| JK 103 / 32-3 | Ergoline/ Flair 32/3 Super Power
(15 min) | - |
| JK 103 / 32-3 | Ergoline/ Flair 32/3 Super Power
(20 min) | - |
Device trade name: Sun Angel sunlamp products Common name: Sun Angel sunlamp products
The following table presents the Sun Angel sunlamp products (no conversion kits).
| Model-No.: | Sun Angel sunlamp products: |
|---|---|
| JK 103 / SA 40-3 AC | SUNANGEL 400 |
| JK 127 / SA 52-4 TT | SUN ANGEL DUO 1400 (12 min) |
| JK 127 / SA 52-4 TT | SUN ANGEL DUO 1400 (15 min) |
| JK 126 / SA 42-4 AC | SUN ANGEL DUO 600 (20 min) |
| JK 126 / SA 42-4 AC | SUN ANGEL DUO 600 (15 min) |
| JK 100 / SA 52-4 TT | Sun Angel S 52 (20 min) |
| JK 100 / SA 52-4 TT | Sun Angel S 52 (15 min) |
| JK 104 / SA 46-3 TT | Sun Angel S 46 |
| JK 132 / SA 52-4 TT | Sun Angel Duo S 52 (20 min) |
| JK 132 / SA 52-4 TT | Sun Angel Duo S 52 (15 min) |
6
Device trade name: Soltron sunlamp products Common name: Soltron sunlamp products
The following table presents the Soltron sunlamp products (no conversion kits).
| Model-No.: | Soltron sunlamp products: |
|---|---|
| JK 103 / 32-0 | Soltron/XXS-30 Super Power (Mango Tango) |
| JK 79 / 52-4 TT | Soltron/XXL-110 DYNAMIC POWER (Blueberry Blue) |
| JK 79 / 48-4 TT | Soltron/XL-80 DYNAMIC POWER (Magic Melon) |
| JK 103 / 34-3 | Soltron/Coco Cabana XXS-35 |
Device trade name: Sundash sunlamp products Common name: Sundash sunlamp products
The following table presents the Sundash sunlamp products in comparison to Soltron private label devices.
The basic products can be upgraded with the conversion kit to Soltron private label sunlamp products.
The Ergoline, Soltron, Sun Angel, Sundash or Palm Beach Tan private label sunlamp products contain the same basic products, which are the technical fundament for different product lines. The conversion kit only serves to label the basic product as a Soltron or Palm Beach Tan private label sunlamp product. It does not alter any technical specification or aspect of the devices.
| Model-No.: | Ergoline sunlamp products: | Conversion Kit /
Private Label: |
|---------------|--------------------------------------|------------------------------------|
| JK 103 / 32-0 | SUNDASH 32 Super Power | XXS-35 SURF |
| JK 103 / 32-1 | SUNDASH 32/1 Super Power
(15 min) | XXS-35 SURF |
| JK 103 / 32-1 | SUNDASH 32/1 Super Power
(20 min) | XXS-35 SURF |
Device trade name: Palm Beach Tan sunlamp products Common name: Palm Beach Tan sunlamp products
The following table presents the Palm Beach Tan sunlamp products (no conversion kits).
| Model-No.: | Ergoline sunlamp products: |
|---|---|
| JK 103 / 32-0 | Palm Beach Tan / SIGNATURE |
7
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 and a mechanical structure.
Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
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 longterm tanning results.
Intended Use:
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.
Predicate devices:
All proposed devices are currently listed as Class I devices (510(k) exempt sunlamp product) and are legally offered for sale before September 2, 2014. In accordance with the final order these devices are used as predicate devices for substantial equivalence purposes.
8
Comparison to predicate devices:
The following table presents the technological characteristics and parameters of the identified predicate devices and the proposed devices.
| Model No. | Conversion Kit | Brand and type name | Body Lamps | Watts | High Pressure Face | Watts | UV-B facial lamps | Watts | Shoulder Lamps | Watts | Max. exposure time [min] |
|---|---|---|---|---|---|---|---|---|---|---|---|
| JK 103 / 32-0 | Soltron/XXS-35 SURF | SUNDASH 32 Super Power | 32 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 32-0 | Palm Beach Tan - SIGNITURE | Palm Beach Tan / SIGNATURE | 32 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 32-0 | Soltron/XXS-30 Super Power | 32 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 15 | |
| JK 103 / 32-1 | Soltron/XXS-35 SURF | SUNDASH 32/1 Super Power | 32 | 120 | 1 | 400 | N/A | N/A | N/A | N/A | 15 |
| JK 103 / 32-1 | Soltron/XXS-35 SURF | SUNDASH 32/1 Super Power | 32 | 120 | 1 | 400 | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 34-3 | Soltron/XS-40 KISS | Ergoline/PASSION 34/3 Super Power | 34 | 120 | 3 | 400 | 2 | 8 | N/A | N/A | 15 |
| JK 103 / 40-3 | Soltron/S-45 FLIRT | Ergoline/PASSION 40/3 Turbo Power | |||||||||
| (white) | 40 | 160/120 | 3 | 400 | 2 | 8 | N/A | N/A | 15 | ||
| JK 103 / 40-3 | Soltron/S-45 FLIRT | Ergoline/PASSION 40/3 Turbo Power | |||||||||
| (black) | 40 | 160/120 | 3 | 400 | 2 | 8 | N/A | N/A | 15 | ||
| JK 103 / 40-3 AC | Soltron/S-45 FLIRT+AC | Ergoline/PASSION PLUS 40/3 Turbo Power | |||||||||
| (white) | 40 | 160 | 3 | 400 | 2 | 8 | N/A | N/A | 12 | ||
| JK 103 / 40-3 AC | Soltron/S-45 FLIRT+AC | Ergoline/PASSION PLUS 40/3 Turbo Power | |||||||||
| (black) | 40 | 160 | 3 | 400 | 2 | 8 | N/A | N/A | 12 | ||
| JK 103 / SA 40-3 AC | SUNANGEL 400 | 40 | 160 | 3 | 400 | 2 | 8 | N/A | N/A | 15 | |
| JK 116 / 48-0 | Soltron/V-50 SPACE CAB | Ergoline/ ESSENCE 48 SMART POWER | 48 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | 9 |
| Model No. | Conversion Kit | Brand and type name | Body Lamps | Watts | High Pressure Face | Watts | UV-B facial lamps | Watts | Shoulder Lamps | Watts | Max. exposure time [min] |
| JK 116 / 48-0 | - | Ergoline/ ESSENCE 48 SMART POWER | 48 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | 9 |
| JK 126 / 38-3 AC | Soltron/M-55 RACER | Ergoline/Inspiration 500 Smart | |||||||||
| Performance | 38 | 160/180 | 3 | 400 | 2 | 8 | N/A | N/A | 12 | ||
| JK 126 / 42-4 AC | Soltron/M-60 JUMP | Ergoline/Inspiration 600 Dynamic | |||||||||
| Performance | 42 | 200 | 4 | 400 | 3 | 8 | N/A | N/A | 12 | ||
| JK 126 / SA 42-4 AC | - | SUN ANGEL DUO 600 | 42 | 200 | 4 | 400 | 3 | 8 | N/A | N/A | 20 |
| JK 126 / SA 42-4 AC | - | SUN ANGEL DUO 600 | 42 | 200 | 4 | 400 | 3 | 8 | N/A | N/A | 15 |
| JK 127 / 48-4 TT | Soltron/XXL-115 STARLIGHT | Ergoline/Prestige 1000 Intelligent | |||||||||
| Performance | 48 | 200 | 4 | 500 | 3 | 8 | 2 | 240 | 10 | ||
| JK 127 / 52-4 TT | Soltron/XXL-125 EAGLE | Ergoline/Prestige 1400 Intelligent | |||||||||
| Performance | 52 | 200 | 4 | 520 | 3 | 8 | 2 | 240 | 10 | ||
| JK 127 / SA 52-4 TT | - | SUN ANGEL DUO 1400 | 52 | 200 | 4 | 520 | 3 | 8 | 2 | 240 | 12 |
| JK 127 / SA 52-4 TT | - | SUN ANGEL DUO 1400 | 52 | 200 | 4 | 520 | 3 | 8 | 2 | 240 | 15 |
| JK 127 / SS 48-4-TT | - | Ergoline/Sun Select 1000 Intelligent | |||||||||
| Performance | 48 | 200 | 4 | 500 | 3 | 8 | 2 | 240 | 10 | ||
| JK 127 / SS 52-4 TT | - | Ergoline/Sun Select 1400 Intelligent | |||||||||
| Performance | 52 | 200 | 4 | 520 | 3 | 8 | 2 | 240 | 10 | ||
| JK 155 / 46-3 | Soltron/L-70 BUTTERFLY | Ergoline/AFFINITY 700 Advanced | |||||||||
| Performance | 46 | 160 | 3 | 500 | 2 | 8 | 7 | 25 | 12 | ||
| Model No. | Conversion Kit | Brand and type name | Body Lamps | Watts | High Pressur | ||||||
| ace | Natts | B facial lam | Natts | oulder Lamps | Natts | Max. exposur time [min] | |||||
| JK 155 / 46-3 AC | Soltron/L-70 BUTTERFLY | Ergoline/AFFINITY 700 Advanced | |||||||||
| Performance | 46 | 160 | 3 | 500 | 2 | 8 | 7 | 25 | 12 | ||
| JK 155 / 50-4 TT | Soltron/XL-85 WILDCAT | Ergoline/AFFINITY 900 Advanced | |||||||||
| Performance | 50 | 160 | 4 | 520 | 3 | 8 | 7 | 25 | 12 | ||
| JK 70 / 0-30 | Soltron/XXL-95 SHARK | Ergoline/ Open Sun 1050 | 27 | 580 | 3 | 640 | N/A | N/A | N/A | N/A | 12 |
| JK 79 / 48-4 TT | Soltron/ XL-80 DYNAMIC POWER | 48 | 200 | 4 | 520 | N/A | N/A | 2 | 240 | 10 | |
| JK 79 / 52-4 TT | Soltron/ XXL-110 DYNAMIC POWER | 52 | 200 | पी | 520 | 3 | 8 | 2 | 240 | 10 | |
| JK 92 / 43-3 | Ergoline/AFFINITY 500 Turbo Power | 43 | 160 | 3 | 500 | N/A | N/A | 7 | 25 | 12 | |
| JK 92 / 46-3-AC | - | Ergoline/AFFINITY 600 Turbo Power Air | |||||||||
| Condition | 46 | 160 | 3 | 500 | N/A | N/A | 7 | 25 | 12 | ||
| JK 92 / 51-4 TT | Ergoline/AFFINITY 800 Turbo Power | ||||||||||
| Temptronic | 50 | 160 | 4 | 520 | N/A | N/A | 7 | 25 | 12 | ||
| JK 98 / 48-0 | Soltron/V-55 UNIVERSE | Ergoline/SUNRISE 480 Turbo Power | 48 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | ರಿ |
| JK 98 / 48-0 | Soltron/V-55 UNIVERSE | Ergoline/SUNRISE 480 Turbo Power | 48 | 200 | N/A | N/A | N/A | N/A | N/A | N/A | ರಿ |
| JK 116 / 48-0 | ESSENCE 48 10 MN PBT | 48 | 160 | N/A | N/A | N/A | N/A | N/A | N/A | 10 | |
| JK 100 / SA 52-4 TT | Sun Angel S52 20 min | ||||||||||
| (with Sensor 3) | 52 | 200 | ব | 520 | 3 | 8 | 2 | 240 | 20 | ||
| JK 100 / SA 52-4 TT | Sun Angel S52 15 min | ||||||||||
| (with Sensor 3) | 52 | 200 | イ | 520 | 3 | 8 | 2 | 240 | ਹੈ ਟ | ||
| JK 104 / SA 46-3 TT | Sun Angel S46 20 min | ||||||||||
| (with Sensor 3) | 46 | 200 | 3 | 520 | 2 | 8 | 7 | 25 | 20 | ||
| JK 132 / SA 52-4 TT | Sun Angel Duo S52 20 min | ||||||||||
| (with Sensor 3) | 52 | 200 | ব | 520 | 3 | 8 | 2 | 240 | 20 | ||
| Model No. | Conversion Kit | Brand and type name | Body Lamps | Watts | High Pressure Face | Watts | UV-B facial lamps | Watts | Shoulder Lamps | Watts | Max. exposure time [min] |
| JK 132 / SA 52-4 TT | - | Sun Angel Duo S52 15 min | |||||||||
| (with Sensor 3) | 52 | 200 | 4 | 520 | 3 | 8 | 2 | 240 | 15 | ||
| JK 103 / 34-0 | - | Passion 34/0 20 min | 34 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 34-0 | - | Passion 34/0 15min | 34 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 15 |
| JK 103 / 32-0 | - | Flair 32/0 20 min | 32 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 32-0 | - | Flair 32/0 15 min | 32 | 120 | N/A | N/A | N/A | N/A | N/A | N/A | 15 |
| JK 103 / 32-1 | - | Flair 32/1 20 min | 32 | 120 | 1 | 400 | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 32-1 | - | Flair 32/1 15 min | 32 | 120 | 1 | 400 | N/A | N/A | N/A | N/A | 15 |
| JK 103 / 32-3 | - | Flair 32/3 15 min | 32 | 120 | 3 | 400 | N/A | N/A | N/A | N/A | 15 |
| JK 103 / 32-3 | - | Flair 32/3 20 min | 32 | 120 | 3 | 400 | N/A | N/A | N/A | N/A | 20 |
| JK 103 / 34-3 | - | Coco Cabana XXS-35 34/3 15min | 34 | 120 | 3 | 400 | 2 | 8 | N/A | N/A | 15 |
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Summary of performed tests:
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 (IEC 60335-2-27 and UL482) and EMC in accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2).
The spectral emission of all sunlamp products was measured. The test procedure for measuring the spectral emission is in accordance with IEC 60335-2-27.
The irradiance ratio limits of all proposed sunlamp products are in accordance with 21 CFR 1040.20 (c) (1). The maximum timer intervals and exposure schedules have been determined according to FDA's "policy on maximum timer interval and exposure schedule for sunlamp products"
Conclusion:
JK Holding GmbH believes that the Ergoline, Soltron, Sun Angel, Sundash and Palm Beach Tan private label sunlamp products are substantially equivalent to currently legally marketed devices. Also all Special Controls as demanded by the Final Order are fulfilled. These devices do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.