Tanning Lamp

K221523 · Unilam Co., Ltd. · LEJ · Feb 15, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K221523
• Device Name: Tanning Lamp
• Applicant: Unilam Co., Ltd.
• Product Code: LEJ · General, Plastic Surgery
• Decision Date: Feb 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4635
• Device Class: Class 2

Intended Use

These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.

Device Story

Unilam Tanning Lamps are high-pressure metal-halide lamps; quartz glass bulb contains metal halide, mercury, and argon gas; equipped with two electrodes and electrical connector. Device emits UV-A (315-400nm) and UV-B (280-315nm) radiation to tan human skin; quartz bulb filters out UVC radiation. Used in tanning equipment; operated by consumers in over-the-counter settings. Output is ultraviolet radiation; effect is skin tanning.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing comparing spectral output and compliance with 21 CFR 1040.20 performance standards.

Technological Characteristics

High-pressure metal-halide lamp; quartz glass bulb; metal halide, mercury, and argon gas fill; two electrodes; electrical connector. Radiates UV-A (315-400nm) and UV-B (280-315nm); UVC filtered by quartz bulb. Operates at 60 Hz. Complies with 21 CFR 1040.20.

Indications for Use

Indicated for individuals seeking to tan the skin via exposure to UV-A and UV-B radiation.

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

• Ultraviolet Sun Tanning Lamp (K151674)

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 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 15, 2023

Unilam Co., Ltd. % Edward Park RA Director Allura Medical Solutions Inc. 5485 Rathdrum Way Antioch, California 94531

Re: K221523

Trade/Device Name: Tanning Lamp 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: May 26, 2022 Received: May 26, 2022

Dear Edward Park:

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,

# Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221523

Device Name Tanning Lamp

Indications for Use (Describe) These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.

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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Image /page/3/Picture/2 description: The image shows the logo for UNILAM CO., LTD. The word "UNILAM" is written in large, bold, blue letters with a red dot above the "I". Below that, "UNILAM CO., LTD." is written in smaller, black letters.

UNILAM CO., LTD. 23 Samdong-Ro, Samnam-Myeon, Ulju-Gun Ulsan Gwangyeogsi, 689-813, Republic of Korea Tel. [phone] / Fax. [phone]

# 5. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

| Submitter Information: | UNILAM CO., LTD. |
|------------------------|-----------------------------------------------|
| | 23 Samdong-Ro, Samnam-Myeon, Ulju-Gun, Ulsan |
| | Ulsan Gwangyeogsi, 689-813, Republic of Korea |
| | Tel. [phone] / Fax. [phone] |
| | Edward Park |
| Contact Person: | Allura Medical Solution Inc. |
| | 5485 Rathdrum Way, Antioch, CA 94531, USA |
| Date Summary Prepared: | November 16, 2022 |
| | |

### Device Information

| Trade Name(s): | Tanning Lamp |
|----------------------|------------------------------|
| Classification Name: | Ultraviolet lamp for tanning |
| Panel: | General & plastic surgery |
| Product Code: | LEJ |

### Predicate Device

< Predicate device >

- Ultraviolet Sun Tanning Lamp (G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH ● K151674)
### Device Description

The Unilam Tanning lamps are high-pressure metal-halide lamps, each comprised of a quartz glass bulb filled with metal halide, mercury, and argon gas, and equipped with 2 electrodes and an electrical connector, to provide ultraviolet light in order to tan the human body.

### Indications for Use

These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.

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Image /page/4/Picture/2 description: The image shows the logo for UNILAM CO., LTD. The word "UNILAM" is written in large, bold, blue letters with a red dot above the "I". Below that, "UNILAM CO., LTD." is written in smaller, black letters.

UNILAM CO., LTD. 23 Samdong-Ro, Samnam-Myeon, Ulju-Gun Ulsan Gwangyeogsi, 689-813, Republic of Korea Tel. [phone] / Fax. [phone]

#### Summary of the technological characteristics compared to the predicate device

| Features | New Device | Predicate Device |
|----------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Manufacturer | UNILAM CO., LTD. | G.L.E. Gesellschaft für<br>lichttechnische Erzeugnisse mbH |
| Product Name | Unilam Tanning Lamp | Ultraviolet Sun Tanning Lamp |
| 510k Number | K221523 | K151674 |
| Establishment<br>Registration | 3007123863 | 3002553648 |
| Product Code | LEJ | LEJ |
| Regulation<br>Number | 21 CFR 878.4635 | 21 CFR 878.4635 |
| Device<br>Classification<br>Name | Ultraviolet Lamp for Tanning | Ultraviolet Lamp for Tanning |
| Class | II | II |
| Device Model | Various | Various |
| Indications for<br>Use | These devices are UV-A and UV-B<br>lamps intended to provide<br>ultraviolet radiation to tan the skin. | These devices are UV-A and UV-B<br>lamps intended to provide<br>ultraviolet radiation to tan the skin. |
| Sterilization | Not applicable | Not applicable |
| Technical<br>Characteristic | Radiate UVA (315-400nm) and<br>UVB (280-315nm). UVC is cut by<br>the quartz bulb. | Radiate UVA (315-400nm) and<br>UVB (280-315nm). UVC is cut by<br>the quartz bulb. |
| Frequency | 60 Hz | 50-60 Hz |
| Sterilization | Not applicable | Not applicable |
| Biocompatibility | Not applicable | Not applicable |

### Non-Clinical Study performance

Performance testing was conducted comparing the Unilam Tanning Lamp and the predicate device. The subject device emits UV-B and UV-A radiation and fulfill the requirements of 21 CFR 878.4635 and the performance standard 21 CFR 1040.20. The ratio of UV-C (200~260mm) to UV-B (260~320nm) meets the requirement (<0.003) per 21 CFR 1040.20(C)(1) at any distance and direction from the product or lamp.

### Clinical Study performance

Clinical testing was not needed in this 510(k) to support substantial equivalence of the subject device to the predicate device.

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Image /page/5/Picture/2 description: The image shows the logo for UNILAM CO., LTD. The word "UNILAM" is written in large, bold, blue letters, with a red dot above the "I". Below that, "UNILAM CO., LTD." is written in smaller, black letters.

UNILAM CO., LTD. 23 Samdong-Ro, Samnam-Myeon, Ulju-Gun Ulsan Gwangyeogsi, 689-813, Republic of Korea Tel. [phone] / Fax. [phone]

## Conclusion

The subject device tanning lamps use the same metal halide technology that is used in the predicate K151674 device's tanning lamps. Differences between the proposed device and predicate device do not raise new types of questions regarding safety and effectiveness, and performance testing supports that the proposed device can be used safely and effectively for the proposed indications for use. The K221523 device is considered to be substantially equivalent to the predicate K151674.