Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound

K190173 · Jk-Holding GmbH · LEJ · May 10, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190173
• Device Name: Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
• Applicant: Jk-Holding GmbH
• Product Code: LEJ · General, Plastic Surgery
• Decision Date: May 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4635
• Device Class: Class 2

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.

Device Story

Sunlamp product for aesthetic tanning; utilizes artificial UV radiation sources within a mechanical booth structure. Hybrid technology combines UV-A and UV-B lamps with red light lamps to achieve tanning results. User lies inside the booth; device operates via electronic lamp ballasts. Output is controlled UV/red light exposure. Intended for use by adults 18+; operated by the user. Benefits include cosmetic skin tanning. Safety and irradiance characteristics verified against IEC 62471 and 21 CFR 1040.20 standards.

Clinical Evidence

Bench testing only. Compliance verified via biocompatibility testing (ISO 10993), electrical/mechanical safety (IEC 60601-1), EMC (IEC 60601-1-2), and U.S. performance standard 21 CFR 1040.20.

Technological Characteristics

Sunlamp booth; UV-A/UV-B and red light lamps; electronic lamp ballasts. Materials comply with ISO 10993. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62471 (photobiological safety), 21 CFR 1040.20 (performance standard).

Indications for Use

Indicated for aesthetic tanning of human skin for individuals aged 18 and older.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ergoline Inspiration 600 Dynamic Performance (K151400)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" in bold, followed by "ADMINISTRATION" in a smaller font size. The logo is simple and professional, reflecting the organization's role in regulating food and drugs.

JK-Holding GmbH Juergen Gerstenmeier Executive Director Research & Development Koehlershohner Strabe 60 Windhagen, 53578 DE

May 10, 2019

Re: K190173

Trade/Device Name: Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound 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: April 24, 2019 Received: April 26, 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Jennifer Stevenson, Acting 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

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## Indications for Use

510(k) Number (if known) K190173

#### Device Name

Ergoline Inspiration 550 Hybrid Technology Ergoline Planet Fitness 42/4 Hybrid Light Technology

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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# 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 Inspiration 550 Hybrid Technology / Ergoline Planet Fitness 42/4 Hybrid Light Technology and their further private label sunlamp products meets the requirements of 21 CFR 807.92

| Submitter information: | JK-HOLDING GmbH<br>Koehlershohner Strasse 60<br>53578 Windhagen<br>Germany<br>Phone: [phone] / 818-0<br>Fax: [phone] / 818-116 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Facility: | JK-Products GmbH<br>Rottbitzer Strasse 69<br>53604 Bad Honnef<br>Germany<br>Establishment Registration Number: 9615023<br>Owner/Operator Number: 9034303 |
| Official Correspondent: | Juergen Gerstenmeier<br>Koehlershohner Strasse 60<br>53578 Windhagen<br>Germany<br>Phone: [phone] / 818-330<br>Email: [e-mail] |
| US Agent (Contact): | Kevin Hart<br>JK PRODUCTS & SERVICES, INC.<br>411 West Washington Ave Suite B<br>Jonesboro, AR 72401<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | April 18th, 2019 |

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## Device(s) Identification:

| Device trade name: | Ergoline Inspiration 550 Hybrid Technology<br>Ergoline Planet Fitness 42/4 Hybrid Light Technology |
|--------------------|----------------------------------------------------------------------------------------------------|
| Common name: | Sunlamp product |

The following table presents the different variants of the Ergoline Inspiration 550 Hybrid Technology / Ergoline Planet Fitness 42/4 Hybrid Light 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 126 / 42-4 HT | Ergoline Inspiration 550 Hybrid Technology / Sound |
| JK 126 / 42-4 HT AC | Ergoline Inspiration 550 Hybrid Technology / AC / Sound |
| JK 126 / 42-4 HT | Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound |

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. 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.

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#### 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.

#### Legally Marketed Predicate device:

| Device Name: | Ergoline Inspiration 600 Dynamic Performance |
|-----------------------------|----------------------------------------------|
| Model No.: | JK 126 / 42-4 AC |
| 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 |

#### 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<br>JK 126 / 42-4 HT<br>JK 126 / 42-4 AC | Predicate device<br>JK 126 / 42-4 AC | Evaluation |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications for Use | This sunlamp product<br>is intended<br>exclusively for<br>aesthetic tanning of<br>the human skin, for<br>one person at a time,<br>at the age of 18 or<br>above. | This sunlamp product<br>is intended<br>exclusively for<br>cosmetic tanning of<br>the human skin, for<br>one person at a time,<br>at the age of 18 or<br>above. | Identical |
| Number of body lamps | 42 (28 UV lamps and<br>14 UV+Red Light<br>lamps) | 42 (all UV lamps) | Similar:<br>The irradiance<br>characteristics are<br>comparable. The safety<br>has been confirmed<br>additionally by<br>corresponding tests in<br>accordance with IEC<br>62471.<br>In terms of functionality<br>and safety there is no<br>impact due to this<br>difference. |
| Parameter | Proposed device<br>JK 126 / 42-4 HT<br>JK 126 / 42-4 HT AC | Predicate device<br>JK 126 / 42-4 AC | Evaluation |
| Watts | Canopy: 160<br>Bench: 180 | 200 | Similar:<br>The lamp wattage is<br>less with the proposed<br>device due to the use<br>of different electronic<br>lamp ballasts and a<br>more efficient lamp-<br>ballast system. |
| Lamp item description | Canopy: GENESIS<br>Type U Hybrid<br>Performance 160 W<br>(UV light) and<br>GENESIS Type R<br>Hybrid Performance -<br>160 W<br>(Mix of UV+Red Light)<br>Bench: GENESIS<br>Type U Hybrid<br>Performance 180 W<br>(UV light) and<br>GENESIS Type R<br>Hybrid Performance -<br>180 W<br>(Mix of UV+Red Light) | GENESIS VHP12<br>Dynamic Power<br>200 W | Similar:<br>The irradiance<br>characteristics are<br>comparable. The safety<br>has been confirmed<br>additionally by<br>corresponding tests in<br>accordance with IEC<br>62471.<br>In terms of functionality<br>and safety there is no<br>impact due to this<br>difference |
| Number of High<br>Pressure Facial lamps | 4 | 4 | Identical |
| Watts | 400 | 400 | Identical |
| Lamp item description | Ergoline Ultra 520W | Ergoline Ultra 520W | Identical |
| Filter | Ultra Performance<br>862H | Ultra Performance<br>862H | Identical |
| Number of Low<br>Pressure Facial lamps | 3 | 3 | Identical |
| Watts | 8 | 8 | Identical |
| Parameter | Proposed device<br>JK 126 / 42-4 HT<br>JK 126 / 42-4 HT AC | Predicate device<br>JK 126 / 42-4 AC | Evaluation |
| Lamp item description | Genesis Type R<br>Hybrid 8W (Mix of<br>UV+Red Light) | Genesis VHP B-Power<br>E9 8W | Similar:<br>The irradiance<br>characteristics are<br>comparable. The<br>safety has been<br>confirmed additionally<br>by corresponding tests<br>in accordance with IEC<br>62471.<br>In terms of functionality<br>and safety there is no<br>impact due to this<br>difference |
| Electrical requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical |
| Total power<br>consumption [Watts] | 11200 | 13200 | Similar:<br>The total power<br>consumption is less<br>with the proposed<br>device due to the use<br>of different electronic<br>lamp ballasts. The<br>irradiance<br>characteristics are<br>comparable. |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical |
| Max exposure time | 12 | 12 | Identical |
| Irradiance ratio in<br>accordance with<br>1040.20 | fulfilled | fulfilled | Identical |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Identical |
| Electromagnetic<br>compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Identical |

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Attachment 10

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#### 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.