KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

K191881 · Kbl GmbH · LEJ · Oct 28, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191881
• Device Name: KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
• Applicant: Kbl GmbH
• Product Code: LEJ · General, Plastic Surgery
• Decision Date: Oct 28, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4635
• Device Class: Class 2

Intended Use

KBL Sunlamp Hybrid 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.

Device Story

KBL Sunlamp Hybrid Products are whole-body tanning devices consisting of a mechanical structure equipped with artificial light sources (hybrid light technology). The device emits ultraviolet radiation (UVA and UVB) and radiation in the visual range of the light spectrum. The user lies on a bench during operation. The device is intended for over-the-counter use by adults to induce skin tanning. The system includes canopy and bench lamp configurations, facial lamps, shoulder lamps, and beautyBooster LEDs. The device is operated by the user. Clinical benefit is limited to cosmetic skin tanning.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993), electrical/mechanical safety (IEC 60601-1, IEC 60335-1, UL482), electromagnetic compatibility (IEC 60601-1-2), spectral emission measurements (IEC 60335-2-27), and performance standards testing (21 CFR 1040.20). Software verification and validation were performed per FDA guidance.

Technological Characteristics

Whole-body tanning booth; hybrid light technology (UV and visual spectrum). Materials: biocompatible per ISO 10993. Energy: electrical, UV/visual lamps, and LEDs. Connectivity: not specified. Sterilization: not applicable. Software: verification and validation performed per FDA guidance. Standards: IEC 60601-1, IEC 60335-2-27, 21 CFR 1040.20.

Indications for Use

Indicated for tanning of the human skin of an adult person.

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

• KBL 7900 alpha (K151962)
• KBL 6800 alpha (K151962)

Submission Summary (Full Text)

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October 28, 2019

KBL GmbH Ralf de Andreis Director Operations Ringstrasse 24-26 Dernbach, 56307 De

Re: K191881

Trade/Device Name: KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun 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: September 24, 2019 Received: September 26, 2019

Dear Ralf de Andreis:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FOR (Neil Ogden) Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Office of Surgical & Infection Control Devices Office of Product Evaluation and Ouality 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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Indications for Use (Describe)

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)

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)

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Image /page/3/Picture/1 description: The image shows the logo for KBL GmbH, The Beauty & Health Company. The logo features a yellow circle with white lines on the left, followed by the letters "KBL" in gray. The words "GmbH" and "The Beauty & Health Company" are in a smaller font size and are located to the right and below the letters "KBL", respectively.

# 510(k) SUMMARY

(according to 21 CFR 807.92)

#### 1. GENERAL INFORMATION

| Submitter: | KBL GmbH<br>Ringstrasse 24-26, 56307 Dernbach, GERMANY<br>Phone: [phone]<br>Fax: [phone]<br>Establishment registration no. 3006116732 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Ralf de Andreis<br>Ringstrasse 24-26, 56307 Dernbach, GERMANY<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Designated U.S. Agent (Contact): | Shepard Bentley<br>Bentley Biomedical Consulting LLC<br>28241 Crown Valley Parkway, Suite 510(k)<br>Laguna Niguel, CA 92677, USA<br>Phone: [phone]<br>E-Mail: [e-mail] |
| Preparation date: | June 27, 2019 |

## 2. PROPOSED DEVICE(S)

| Device Name | KBL Sunlamp Hybrid Products |
|----------------------------|----------------------------------------------------------------------------------|
| Device Trade Name(s) | KBL 7000 alpha hybridSun<br>KBL 7900 alpha hybridSun<br>KBL 8000 alpha hybridSun |
| Device common name | Tanning device |
| Device Classification Name | Booth, Sun Tan |
| Product Code | LEJ (21CFR 878.4635) |
| Classification Panel | General & Plastic Surgery |
| Device Class | Class II - Special Controls |

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Image /page/4/Picture/0 description: The image shows the logo for KBL GmbH, a beauty and health company. The logo features a yellow circle with white lines, followed by the letters "KBL" in gray. Below the letters is the phrase "The Beauty & Health Company" in a smaller font, also in gray.

# 3. PREDICATE DEVICE(S)

| Device Name | KBL Sunlamp Products |
|----------------------------|----------------------------------|
| Device Trade Name(s) | KBL 7900 alpha<br>KBL 6800 alpha |
| Device common name | Tanning device |
| Device Classification Name | Booth, Sun Tan |
| Product Code | LEJ (21CFR 878.4635) |

levice n Tan FR 878.4635) General & Plastic Surgery Class II - Special Controls K151962

### 4. DEVICE DESCRIPTION

Classification Panel

Device Class

510(k) No.

KBL Sunlamp Hybrid Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources using the hybrid light technology. The hybrid light technology produces ultraviolet radiation and radiation in the visual range of the light spectrum.

The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The user is lying on a bench.

#### 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 Hybrid 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 is a logo for KBL GmbH, The Beauty & Health Company. The logo features a yellow circle with lines emanating from the center, followed by the letters "KBL" in gray. The words "The Beauty & Health Company" are written in a smaller font below the letters, and the letters "GmbH" are written in a smaller font to the right of the letter "L".

# 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. See table 2, 3 and 4 below:

| Table 2 | PROPOSED DEVICE | PREDICATE DEVICE | EVALUATION |
|--------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | KBL Sunlamp Hybrid Product | KBL Sunlamp Product | |
| Device Trade Name | KBL 7000 alpha hybridSun | KBL 6800 alpha | N/A |
| Number of Lamps<br>Canopy | 18x pureSunlight lamps /<br>8x smartSunlight (uv+red light)<br>lamps | 20x megaLine lamps /<br>6x megaLine lamps / | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed<br>by appropriate tests according to IEC<br>62471. In terms of funtionality and |
| Watt | 160 | 160 / 80 | safety there is no impact due to this<br>difference. |
| Number of Lamps<br>Bench | 14x pureSunlight lamps /<br>6x smartSunlight (uv+red light)<br>lamps | 20x megaLine lamps | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed<br>by appropriate tests according to IEC<br>62471. In terms of functionality and<br>safety there is no impact due to this |
| Watt | 180 | 180 | difference. |
| Number of<br>Facial Lamps | 4x megaLine HP 800 | 4x megaLine HP 800 | Identical |
| Watt | 600 | 600 | Identical |
| Number of<br>Shoulder Lamps | 2x ms 250 | 2x ms 250 | Identical |
| Watt | 250 | 250 | Identical |
| Number of LEDs<br>(vis red light) | 40x beautyBooster | 40x Enhanced LED<br>Illumination | Identical |
| Watt | 1 | 1 | Identical |
| Max. Exposure<br>Time in min. | 10 | 10 | Identical |
| Dimensions in<br>Inches<br>(height x width x<br>depth) | when closed<br>~60,59"x ~93,86"x ~56,34"<br>when open<br>~80,24"x ~93,86"x ~56,34" | when closed:<br>~60,39"x ~93,86"x<br>~56,34"<br>when open:<br>~76,46"x ~93,86"x<br>~56,34" | Equivalent<br>The dimensions are equivalent to the<br>predicate device. In terms of<br>functionality and safety there is no<br>impact due to this difference. |

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Image /page/6/Picture/0 description: The image shows the logo for KBL GmbH, a company focused on beauty and health. The logo features the letters "KBL" in a bold, sans-serif font, with "GmbH" in a smaller font to the right of the "L". Below the letters is a horizontal line, and below that is the text "The Beauty & Health Company" in a smaller, lighter font.

| Table 3 | PROPOSED DEVICE<br>KBL Sunlamp Hybrid Product | PREDICATE DEVICE<br>KBL Sunlamp Product | EVALUATION |
|-----------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade name | KBL 7900 alpha hybridSun | KBL 7900 alpha | N/A |
| Number of<br>Lamps Canopy | 18x pureSunlight lamps /<br>8x smartSunlight (uv+red light)<br>lamps | 20x megaLine lamps /<br>6x megaLine lamps / | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed<br>by appropriate tests according to IEC<br>62471. In terms of functionality and<br>safety there is no impact due to this<br>difference. |
| Watt | 160 | 160 / 80 | difference. |
| Number of<br>Lamps Bench | 16x pureSunlight lamps /<br>8x smartSunlight (uv+red light)<br>lamps | 24x megaLine lamps | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed<br>by appropriate tests according to IEC<br>62471. In terms of functionality and<br>safety there is no impact due to this<br>difference. |
| Watt | 180 | 180 | difference. |
| Number of<br>Facial Lamps | 4x megaLine HP 800 | 4x megaLine HP 800 | Identical |
| Watt | 600 | 600 | Identical |
| Number of LEDs<br>(vis red light) | 40x beautyBooster | 40x Enhanced LED<br>Illumination | Identical |
| Watt | 1 | 1 | Identical |
| Number of<br>Shoulder Lamps | 2x ms 250 | 2x ms 250 | Identical |
| Watt | 250 | 250 | Identical |
| Max. Exposure<br>Time in min. | 10 | 10 | Identical |
| Dimensions in Inches<br>(height x width x<br>depth) | when closed<br>~67,44"x~93,86"x~56,34"<br>when open<br>~82,16"x~93,86"x~56,34" | when closed<br>~67,44"x ~93,86"x<br>~56,34"<br>when open<br>~82,16"x ~93,86"x<br>~56,34" | Identical |
| Table 4 | PROPOSED DEVICE<br>KBL Sunlamp Hybrid Product | PREDICATE DEVICE<br>KBL Sunlamp Product | EVALUATION |
| Device Trade name | KBL 8000 alpha hybridSun | KBL 7900 alpha | N/A |
| Number of Lamps<br>Canopy | 18x pureSunlight lamps /<br>8x smartSunlight (uv+red light)<br>lamps | 20x megaLine lamps /<br>6x megaLine lamps / | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed by<br>appropriate tests according to IEC<br>62471. In terms of functionality and<br>safety there is no impact due to this |
| Watt | 160 | 160 / 80 | difference. |
| Number of Lamps<br>Bench | 16x pureSunlight lamps /<br>8x smartSunlight (uv+red light)<br>lamps | 24x megaLine lamps | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed by<br>appropriate tests according to IEC<br>62471. In terms of functionality and<br>safety there is no impact due to this |
| Watt | 180 | 180 | difference. |
| Number of Facial<br>Lamps | 4x megaLine HP 800 | 4x megaLine HP 800 | Identical |
| Watt | 600 | 600 | Identical |
| Number of Shoulder<br>Lamps | 2x ms 250 | 2x ms 250 | Identical |
| Watt | 250 | 250 | Identical |
| Number of LEDs<br>(vis red light) | 70x beautyBooster | 40x Enhanced LED<br>Illumination | Equivalent<br>The irradiance characteristics are still<br>equivalent to the predicate device as<br>provided under Performance Testing<br>table (radiometric measurement<br>results). The safety was confirmed by<br>appropriate tests according to IEC<br>62471. In terms of functionality and<br>safety there is no impact due to this<br>difference. |
| Watt | 1 | 1 | Identical |
| Max. Exposure Time<br>in min. | 10 | 10 | Identical |
| Dimensions in Inches<br>(height x width x<br>depth) | when closed:<br>~67,44"x~93,86"x~56,34"<br>when open:<br>~82,16"x ~93,86"x ~56,34" | when closed~67,44"x<br>~93,86"x ~56,34"<br>when open: ~82,16"x<br>~93.86"x ~56.34" | Identical |

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Image /page/7/Picture/0 description: The image shows the logo for KBL GmbH, The Beauty & Health Company. The logo features a yellow circle with white lines inside, followed by the letters "KBL" in gray. The words "The Beauty & Health Company" are written in gray below a yellow line, and the letters "GmbH" are written in gray to the right of the "L" in "KBL".

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Image /page/8/Picture/0 description: The image shows the logo for KBL GmbH, The Beauty & Health Company. The logo features a yellow circle with lines emanating from the center, 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 a smaller, gray font.

# 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 60601-1:2005 + Corr.:2006 + Corr.:2007 + A1:2012 (IEC 60335-1:2012, and UL482:2005/09/02 Ed.9 Rev. 2013/10/03)
- Electromagnetic compatibility testing in compliance with IEC 60601-1-2:2014. .
- . Spectral emission measurement based on the test procedure for measuring the spectral emission in accordance to IEC 60335-2-27:2013.
- 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 GmbH 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