Sunrise 6200, Sunrise 7200

K173565 · Jk-Holding GmbH · LEJ · Feb 14, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173565
• Device Name: Sunrise 6200, Sunrise 7200
• Applicant: Jk-Holding GmbH
• Product Code: LEJ · General, Plastic Surgery
• Decision Date: Feb 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4635
• Device Class: Class 2

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.

Device Story

The Sunrise 6200 and 7200 are stand-up tanning booths utilizing 48 artificial UV lamps (200W each) to emit UV-A and UV-B radiation. The device is operated by a single user at a time in a clinic or salon setting. The system uses electronic ballasts to improve energy efficiency compared to magnetic ballasts used in the predicate. Optional features include sound systems, Bluetooth connectivity, and Vibra Shape vibration plates. The device is controlled via an interface to manage exposure time, which is capped at 9 minutes. The primary benefit is cosmetic skin tanning. No clinical decision-making or diagnostic output is involved.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility (ISO 10993), electrical/mechanical safety (IEC 60601-1, UL 482, IEC 60335-2-27), and electromagnetic compatibility (IEC 60601-1-2). Compliance with U.S. performance standard 21 CFR 1040.20 was verified.

Technological Characteristics

Stand-up tanning booth; 48 UV lamps (200W each); electronic ballasts; 230V power supply. Materials: mechanical structure. Standards: 21 CFR 1040.20, IEC 60601-1, IEC 60601-1-2, UL 482, IEC 60335-2-27, ISO 10993. Connectivity: Bluetooth (select models).

Indications for Use

Indicated for cosmetic tanning of human skin for individuals aged 18 or older. Contraindicated for individuals under 18 years of age.

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

• Sunrise 480 (K151400)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 2018

JK-Holding GmbH Juergen Gerstenmeier Director Research & Development Koehlershohner Strasse 60 Windhagen, 53578 De

Re: K173565

Trade/Device Name: Sunrise 6200, Sunrise 7200 Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: November 10, 2017 Received: November 17, 2017

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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.

# Jennifer R. Stevenson -S3

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}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### K173565

Device Name Sunrise 6200 and Sunrise 7200

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 Sunrise 6200 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<br>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 | 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: | November 10th, 2017 |

{4}------------------------------------------------

## Device(s) Identification:

| Device trade name: | Ergoline Sunrise 6200 and Ergoline Sunrise 7200 |
|--------------------|-------------------------------------------------|
| Common name: | Sunlamp product |

The following table presents the different variants of the Ergoline Sunrise 6200 and Ergoline Sunrise 7200 Stand-Up booth.

All variants use the same basic device technology and differ only in effect lighting, comfort features and private labelling.

| Model-No.: | Variant Name: |
|------------------|-------------------------------------------------------------------------|
| JK 158 / 48-0 | Ergoline Sunrise 6200 Basic Design |
| JK 158 / 48-0 | Ergoline Sunrise 6200 Planet Fitness |
| JK 158 / 48-0 | Ergoline Sunrise 6200 Basic Design / Sound |
| JK 158 / 48-0 | Ergoline Sunrise 6200 Planet Fitness / Sound |
| JK 158 / 48-0 VS | Ergoline Sunrise 6200 Basic Design / Sound / Vibra Shape |
| JK 158 / 48-0 VS | Ergoline Sunrise 6200 Planet Fitness / Sound / Vibra Shape |
| JK 158 / 48-0 | Ergoline Sunrise 7200 Advanced Design / Sound / Bluetooth |
| JK 158 / 48-0 VS | Ergoline Sunrise 7200 Advanced Design / 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.

For further information concerning conversion kits please refer to chapter 11.

### 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 (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.

{5}------------------------------------------------

#### 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.

#### Legally Marketed Predicate device:

| Device Name: | Sunrise 480 |
|-----------------------------|---------------------------|
| Model No.: | JK 98 / 48-0 |
| 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 | Predicate device<br>JK 98 / 48-0 | Proposed device<br>JK 158 / 48-0<br>JK 158 / 48-0 VS | Evaluation |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications for Use | 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. | 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 | 48 | 48 | Identical |
| Watts | 200 | 200 | Identical |
| Lamp item description | GENESIS VHP12<br>Turbo Power - 200 W | GENESIS VHP9<br>Smart Performance<br>200 W | Different description;<br>identical nominal lamp<br>wattage |
| Max exposure time<br>[min] | 9 | 9 | identical |
| Electrical requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical |
| Total power<br>consumption [Watts] | 11300 | 9500 | Similar: less power<br>consumption due to<br>the use of electronic<br>ballasts instead of<br>magnetic ballasts.<br>Performance is not<br>impaired. |

{6}------------------------------------------------

| Parameter | Predicate device<br>JK 98 / 48-0 | Proposed device<br>JK 158 / 48-0<br>JK 158 / 48-0 VS | Evaluation |
|-------------------------------------------------------------|-----------------------------------------|------------------------------------------------------|-------------------------------------------------------------|
| Rated overcurrent<br>protection device<br>(circuit breaker) | 40A / 3-pole 3Ø or<br>70A / 2-pole 2Ø | 40A / 3-pole 3Ø or<br>70A / 2-pole 2Ø | identical. |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | identical |
| Irradiance ratio in<br>accordance with<br>1040.20 | fulfilled | fulfilled | identical<br>(refer to section 18 for<br>bench test report) |
| Electrical safety | IEC 60601-1<br>UL 482<br>IEC 60335-2-27 | IEC 60601-1<br>UL 482<br>IEC 60335-2-27 | identical |
| Electromagnetic<br>compatibility | IEC 60601-1-2 | IEC 60601-1-2 | identical |

### 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.