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.

AI/ML Overview

The provided document is a 510(k) summary for a "Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving algorithms, AI, or human readers. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment for such studies is not available in the document.

However, I can extract the information related to the device's performance criteria mentioned in the document as part of its substantial equivalence claim.

Here's the relevant information based on the document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Regulatory Standard)	Reported Device Performance
Requirements of 21 CFR 878.4635 (Sunlamp Products and Ultraviolet Lamps)	The subject device emits UV-B and UV-A radiation and fulfills the requirements of 21 CFR 878.4635.
Performance standard 21 CFR 1040.20 (Sunlamp Products)	The subject device fulfills the requirements of 21 CFR 1040.20.
Ratio of UV-C (200-260nm) to UV-B (260-320nm) < 0.003 (per 21 CFR 1040.20(C)(1)) at any distance and direction from the product or lamp	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. Additionally, UVC is cut by the quartz bulb (Technical Characteristic).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The study performed was a non-clinical performance test of the device's UV emission characteristics against regulatory standards, not involving a test set of data in the context of AI/algorithm performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document describes performance testing of a physical lamp against regulatory standards, not the evaluation of an AI model with expert-annotated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. 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 is not an AI/software device.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the established regulatory standards and performance requirements specified in 21 CFR 878.4635 and 21 CFR 1040.20 for sunlamp products. The device's performance was measured and compared directly to these objective, quantitative standards.

8. The sample size for the training set

Not applicable. This document does not describe the development or training of an AI model.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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. 82-55-372-2509 / Fax. 82-55-372-2513

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. 82-55-372-2509 / Fax. 82-55-372-2513
	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

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. 82-55-372-2509 / Fax. 82-55-372-2513

Summary of the technological characteristics compared to the predicate device

Features	New Device	Predicate Device
Manufacturer	UNILAM CO., LTD.	G.L.E. Gesellschaft fürlichttechnische Erzeugnisse mbH
Product Name	Unilam Tanning Lamp	Ultraviolet Sun Tanning Lamp
510k Number	K221523	K151674
EstablishmentRegistration	3007123863	3002553648
Product Code	LEJ	LEJ
RegulationNumber	21 CFR 878.4635	21 CFR 878.4635
DeviceClassificationName	Ultraviolet Lamp for Tanning	Ultraviolet Lamp for Tanning
Class	II	II
Device Model	Various	Various
Indications forUse	These devices are UV-A and UV-Blamps intended to provideultraviolet radiation to tan the skin.	These devices are UV-A and UV-Blamps intended to provideultraviolet radiation to tan the skin.
Sterilization	Not applicable	Not applicable
TechnicalCharacteristic	Radiate UVA (315-400nm) andUVB (280-315nm). UVC is cut bythe quartz bulb.	Radiate UVA (315-400nm) andUVB (280-315nm). UVC is cut bythe 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. 82-55-372-2509 / Fax. 82-55-372-2513

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.

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.