KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.

Device Description

KBL Sunlamp Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources producing ultraviolet light in the UVA and UVB region of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results. The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).

AI/ML Overview

The provided document is a 510(k) premarket notification for KBL Sunlamp Products, seeking to demonstrate substantial equivalence to legally marketed predicate devices. It describes the devices, their intended use, and provides a comparison of technological characteristics. Crucially, this document does not describe the acceptance criteria and study that proves the device meets specific performance criteria for AI/ML device evaluations as the prompt requests.

Instead, it pertains to sunlamp products and their compliance with electrical, mechanical, and radiation safety standards. Therefore, an AI/ML-specific response is not applicable to the content of this document.

However, I can extract the information relevant to the performance claims and testing described in the document, even though it's not related to AI/ML.

Here's an interpretation based on the document's content, focusing on the device's performance criteria as presented, and acknowledging that it's not an AI/ML device:

Device: KBL Sunlamp Products (various models: KBL 6800 alpha, KBL 7900 alpha, KBL 4800 alpha, KBL 5600 alpha, KBL Tower Space 2000, KBL Tower Space 3000, KBL Tower pureEnergy 5.0).

Intended Use: Over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.

Acceptance Criteria and Reported Device Performance (Non-AI/ML)

Acceptance Criteria Category	Acceptance Criteria Description (General)	Reported Device Performance / Compliance (Summary from document)
Biocompatibility	Device materials in contact with skin must be biocompatible.	Biocompatibility testing performed in accordance with DIN EN ISO 10993-1:2010-04, DIN EN ISO 10993-5:2009-10, and DIN EN ISO 10993-12:2012-10. (Implies compliance, but specific results or pass/fail thresholds are not detailed in this summary).
Electrical and Mechanical Safety	Device must meet relevant electrical and mechanical safety standards to ensure user safety.	Electrical and mechanical safety testing performed according to IEC 60601-1 Ed 3.1 2012/08 (IEC 60335-1:2010, 5th ed. and UL482:2005/09/02 Ed.9 Rev. 2013/10/03). (Implied compliance).
Electromagnetic Compatibility (EMC)	Device must not interfere with or be affected by other electronic devices.	Electromagnetic compatibility testing performed in compliance with IEC 60601-1-2:2007, modified. (Implied compliance).
Spectral Emission	The UV light emitted must be within specific spectral ranges (UVA and UVB) and power levels.	Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance with IEC 60335-2-27:2009, 5th ed. (Implied compliance with the standard's requirements for spectral emission).
Software Verification and Validation	Any embedded software must be verified and validated for correct and safe operation.	Software verification and validation testing performed according to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Implied compliance).
Performance Standards (FDA 21 CFR 1040.20)	Compliance with general performance standards for sunlamp products, including irradiance and timer limits.	Performance Standards testing performed in accordance with 21 CFR 1040.20. Irradiance ratio limits are in accordance with 21 CFR 1040.20(c)(1). Maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products." (Implied compliance with all listed regulations and policies).

Since this document describes a sunlamp product and not an AI/ML device, the following points from the prompt are not applicable:

Sample sizes used for the test set and the data provenance: Not applicable to non-AI/ML device testing as described. The testing refers to engineering and regulatory standards for safety and performance of the physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model's classification or prediction is not relevant here.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This assesses human performance with AI assistance, which is for AI/ML devices.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the engineering and regulatory compliance testing cited.
The sample size for the training set: Not applicable. This is for AI/ML model development.
How the ground truth for the training set was established: Not applicable. This is for AI/ML model development.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three intertwined human profiles facing to the right, symbolizing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

KBL AG Mr. Norbert Becker Head of Technical Department Ringstrasse 24-26 Dernbach, Rheinland-Pfalz, Germany 56307

Re: K151962

Trade/Device Name: KBL Sunlamp Products Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: September 12, 2016 Received: September 14, 2016

Dear Mr. Becker:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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/Resourcesfor You/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,

Christopher J. Ronk -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151962

Device Name

KBL Sunlamp Products

Indications for Use (Describe)

KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and
UVA region of the spectrum intended for tanning of the human skin of an adult person.

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-5740

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Image /page/3/Picture/0 description: The image shows the logo for KBL AG, which is "The Beauty & Health Company". The logo consists of a yellow circle with white lines inside, followed by the letters "KBL" in gray. The letters "AG" are in a smaller font and are located to the right of the "L". A yellow line is underneath the letters, and the text "The Beauty & Health Company" is underneath the yellow line.

510(k) SUMMARY

(according to 21 CFR 807.92)

1. GENERAL INFORMATION

Submitter:	KBL AGRingstrasse 24-2656307 Dernbach, GERMANYPhone: +49 (0) 2689 9426-0Fax: +49 (0) 2689 9426-66
Contact person:	Norbert BeckerRingstrasse 24-2656307 Dernbach, GERMANYPhone: +49 (0) 2689 9426-525Fax: +49 (0) 2689 9426-500E-mail: nbecker@kbl.de

2. PROPOSED DEVICE(S)

Preparation date:

Device Bundling Name:	KBL Sunlamp Product
Trade Name(s):	KBL 6800 alpha / KBL 7900 alphaKBL 4800 alpha / KBL 5600 alphaKBL Tower Space 2000 / KBL Tower Space 3000KBL Tower pure Energy 5.0
Common Name	Tanning device
Classification Name:	Sunlamp product (21 CFR 878.4635, Product Code LEJ)

June 8, 2015

All Proposed Devices have originally been listed as Class I devices (510(k)-exempt sunlamp products) and legally offered for sale before September 2, 2014. In accordance with the Final Order (Federal Register, Volume 79, Number 5) the proposed devices are used as Predicate Devices for Substantial Equivalence purposes.

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Image /page/4/Picture/0 description: The image shows the logo for KBL AG, a beauty and health company. The logo features a yellow circle with white lines inside, followed by the letters "KBL" in gray. Below the letters is a yellow line, and below that is the text "The Beauty & Health Company" in gray.

3. PREDICATE DEVICE(S)

Trade Name(s):	KBL 6800 alpha / KBL 7900 alphaKBL 4800 alpha / KBL 5600 alphaKBL Tower Space 2000 / KBL Tower Space 3000KBL Tower pure Energy 5.0
Common Name	Tanning device
Classification Name:	Sunlamp product (21 CFR 878.4635, Product Code LEJ)

4. DEVICE DESCRIPTION

The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results.

The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).

5. INDICATIONS FOR USE

The Indications for use for the Proposed Devices are identical to the Predicate Devices as shown in Table 1 below:

Table 1

Proposed Device	Predicate Device
KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.	KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.

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Image /page/5/Picture/0 description: The image shows the logo for KBL AG, "The Beauty & Health Company". The logo consists of a yellow circle with white lines inside, followed by the letters "KBL" in gray. The letters "AG" are in smaller font and are located to the right of the "L". Below the letters is a yellow line, and below that is the text "The Beauty & Health Company".

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

We believe that the Technological Characteristics of the Proposed Devices in comparison to the Predicate Devices show that they are substantially equivalent (Table 2).

Brand and type name ↓	Number of Lamps Canopy	Watts	Number of Lamps Bench	Watts	Number of Facial Lamps	Watts	Number of Shoulder Lamps	Watts	Max. Exposure time in min	Dimentions in inches (height x width x depth)
Proposed DeviceKBL 6800 alpha	26 / 0 or20 / 6 or24 / 2	160 / 80	20	180	4	600	2	250	10	when closed:~60,39" x ~93,70" x ~56,30"when open:~76,46" x ~93,70" x ~56,30"
Predicate DeviceKBL 6800 alpha	26 / 0 or20 / 6 or24 / 2	160 / 80	20	180	4	600	2	250	10	when closed:~60,39" x ~93,70" x ~56,30"when open:~76,46" x ~93,70" x ~56,30"
Proposed DeviceKBL 7900 alpha	20 / 6	160 / 80	24	180	4	600	2	250	10	when closed:~67,44" x ~93,70" x ~56,30"when open:~82,16" x ~93,70" x ~56,30"
Predicate DeviceKBL 7900 alpha	20 / 6	160 / 80	24	180	4	600	2	250	10	when closed:~67,44" x ~93,70" x ~56,30"when open:~82,16" x ~93,70" x ~56,30"
Proposed DeviceKBL 4800 alpha	22 / 2	160 / 80	16	180	3	500	N/A	N/A	12	when closed:~53,94 x ~91,74 x ~62,21when open:~67,33 x ~91,74 x ~56,70
Predicate DeviceKBL 4800 alpha	22 / 2	160 / 80	16	180	3	500	N/A	N/A	12	when closed:~53,94 x ~91,74 x ~62,21when open:~67,33 x ~91,74 x ~56,70
Proposed DeviceKBL 5600 alpha	24 / 2	160 / 80	16	180	4	500	N/A	N/A	12	when closed:~58,27 x ~91,74 x ~63,39when open:~70,87 x ~91,74 x ~56,70
Predicate DeviceKBL 5600 alpha	24 / 2	160 / 80	16	180	4	500	N/A	N/A	12	when closed:~58,27 x ~91,74 x ~63,39when open:~70,87 x ~91,74 x ~56,70
Proposed DeviceKBL Tower space 2000	50	180	N/A	N/A	N/A	N/A	N/A	N/A	11	when closed:85.83 x 55.12 x 55.31when open:85.83 x 55.12 x 77.28
Predicate DeviceKBL Tower space 2000	50	180	N/A	N/A	N/A	N/A	N/A	N/A	11	when closed:85.83 x 55.12 x 55.31when open:85.83 x 55.12 x 77.28

Table 2

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Image /page/6/Picture/0 description: The image shows the logo for KBL AG, a beauty and health company. The logo features a yellow circle with lines inside, followed by the letters "KBL" in gray. Below the letters is a yellow line, and below that is the text "The Beauty & Health Company" in gray.

ProposedDeviceKBL Towerspace 3000	52	180	N/A	N/A	N/A	N/A	N/A	N/A	11	when closed:85.83 x 55.12 x 58.98when open:85.83 x 55.12 x 77.09
PredicateDeviceKBL Towerspace 3000	52	180	N/A	N/A	N/A	N/A	N/A	N/A	11	when closed:85.83 x 55.12 x 58.98when open:85.83 x 55.12 x 77.09
ProposedDeviceKBL TowerpureEnergy 5.0	52	200	N/A	N/A	N/A	N/A	N/A	N/A	10	when closed:93,23 x 54,93 x 48,55when open:93,23 x 54,93 x 72,56
PredicateDeviceKBL TowerpureEnergy 5.0	52	200	N/A	N/A	N/A	N/A	N/A	N/A	10	when closed:93,23 x 54,93 x 48,55when open:93,23 x 54,93 x 72,56

7. PERFORMANCE DATA

The following non-clinical performance tests were performed for all proposed KBL sunlamp products:

. Biocompatibility testing in accordance with DIN EN ISO 10993-1:2010-04; DIN EN ISO 10993-5:2009-10; DIN EN ISO 10993-12:2012-10;
. Electrical and mechanical safety testing according to IEC 60601-1 Ed 3.1 2012/08 (IEC 60335-1:2010, 5te ed. and UL482:2005/09/02 Ed.9 Rev. 2013/10/03)
Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2007, modified. ●
. Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance to IEC 60335-2-27:2009, 5th ed.
Software verification and validation testing according to FDA's Guidance for Industry and ● FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
. Performance Standards testing in accordance with 21 CFR 1040.20
Irradiance ratio limits are in accordance with 21 CFR 1040.20(c)(1). .
. Maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products".

8. CONCLUSION

Based on an analysis of the technological characteristics, non-clinical performance data and indications for use, KBL AG believes that the Proposed Devices are substantially equivalent to the legally marketed Predicate Devices and do not raise any new issues of safety and effectiveness.

End of 510(k) Summary

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.