Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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 data sets for training or testing, which are typical indicators of AI/ML technology in medical devices. The performance studies focus on safety and compliance with existing standards for sunlamp products.

Therapeutic

No
The device is exclusively intended for aesthetic tanning of human skin, which is not a therapeutic purpose.

Diagnostic

No

The intended use of the device is for aesthetic tanning, not for diagnosis of any disease or condition.

SaMD (Software as a Medical Device)

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.

IVD (In Vitro Diagnostic)

No, 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 purpose, not a diagnostic one.
Device Description: The device description focuses on the technical components related to UV radiation for tanning, not on analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This sunlamp does none of these things.

The information provided clearly indicates this is a sunlamp for cosmetic tanning, which falls under a different regulatory category than IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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

The proposed device has 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 device is in compliance with U.S. performance standard 21CFR 1040.20. All proposed sunlamp products are in compliance with U.S. performance standard 1040.20.

Key Metrics

Not Found

Predicate Device(s)

K151400

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines.

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

October 11, 2018

Re: K180555

Trade/Device Name: Ergoline Prestige 1600 Hybrid Performance Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: August 7, 2018 Received: August 14, 2018

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Neil R Ogden -S 2018.10.11 08:49:06 -04'00'

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180552

Device Name Ergoline Prestige 1600 Hybrid Performance

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)	☑ 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."

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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 Prestige 1600 Hybrid Performance 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: 961502-
Owner/Operator Number: 9034303 |
| Official Correspondent: | Jürgen 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: | September 07th, 2018 |

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Device(s) Identification:

Device trade name:	Ergoline Prestige 1600 Hybrid Performance
Common name:	Sunlamp product
Model No.:	JK 162 / 52-4 TT HP

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.

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.

Predicate device:

Device Name:	Ergoline/Prestige 1400 Intelligent Performance
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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Comparison to predicate device:

The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed device.

| Parameter | Predicate device
Ergoline/Prestige 1400
Intelligent Performance | Proposed device
Ergoline Prestige
1600 Hybrid
Performance | Evaluation |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 | 52
(all UV lamps) | 52
(38 UV lamps, 14
UV+red light lamps) | 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 | 200 | 200 | Identical |
| Lamp item description | GENESIS VHP10
Intelligent Performance

200 W | GENESIS Type U
Hybrid Performance -
200 W
(UV light)
GENESIS Type R
Hybrid Performance -
200 W
(red light) | 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

6

7

Summary of performance testing:

The proposed device has 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 device is in compliance with U.S. performance standard 21CFR 1040.20. All proposed sunlamp products are in compliance with U.S. performance standard 1040.20.

Conclusion:

JK Holding GmbH believes that the Ergoline Prestige 1600 Hybrid Performance is substantially equivalent to currently legally marketed devices. Also all special controls are fulfilled. This device does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.