Tanning lamp is electronic products to be intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths to induce skin tanning.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tanning Lamp (K143043).

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive clinical study to "prove the device meets acceptance criteria" in the way a novel, high-risk device might. Instead, it relies on demonstrating similar performance to a legally marketed predicate device.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" here are based on the concept of substantial equivalence to the predicate device. This means the new device must perform comparably in key technological characteristics and safety aspects.

Acceptance Criteria (Derived from Substantial Equivalence)	Reported Device Performance (Unilam Tanning Lamp)
Intended Use: Provide ultraviolet light to tan the skin	Intended Use: Provides ultraviolet light to tan the skin (Matches predicate)
Technological Characteristics:	Technological Characteristics:
- Radiate UVA (315~~400nm) and UVB (280~~315nm)	- Radiates UVA (315~~400nm) and UVB (280~~315nm)
- UVC cut by quartz bulb	- UVC cut by quartz bulb
- Power source: Ballast Cosmedico #74427 (input 220V/60Hz)	- Power source: Ballast Cosmedico #74427 (input 220V/60Hz)
- Frequency: 60Hz	- Frequency: 60Hz
- Electrical power requirements for lamp activation (comparable to predicate)	Individual test data sheets prepared; comparable electrical power requirements to predicate
- Lamp spectral output (comparable to predicate)	Individual test data sheets with output spectra in nm increments; comparable spectral output to predicate
- Lamp energy output (UVA and UVB range; comparable to predicate)	Individual test data sheets with energy output for UVA and UVB range; comparable energy output to predicate
- Approximate lifetime of bulbs (comparable to predicate)	Individual test data sheets with approximate lifetime of bulbs; comparable lifetime to predicate
- Physical dimensions and connector design (comparable to predicate)	Individual test data sheets with dimensions and connector design; comparable to predicate
Safety:	Safety:
- Not applicable for sterilization	- Not applicable for sterilization
- Overall safety comparable to predicate (implied by substantial equivalence and lack of new safety concerns)	Demonstrated comparable performance in non-clinical studies suggests similar safety profile to predicate

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the "test" involved direct comparisons of the new device (Unilam UV lamps) and the predicate device (Cosmedico UV lamps) based on their intrinsic properties. It refers to "individual test data sheets" for each bulb. This implies that at least one of each relevant bulb model from Unilam and Cosmedico was tested for the specified parameters.
- Data Provenance: The studies were "Performance studies... comparing the Unilam UV lamps to the predicate Cosmedico UV lamps." This suggests the data was generated specifically for this 510(k) submission, likely in a controlled laboratory setting. The origin of the devices themselves is implied: Unilam Co., Ltd. (Republic of Korea) and NARVA LICHTQUELLEN GMBH + CO KG (predicate). The document does not specify if the tests were retrospective or prospective, but for laboratory performance testing like this, it would be prospective in relation to the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a device like a tanning lamp, the "ground truth" for performance is based on quantifiable physical measurements (wavelengths, energy output, electrical characteristics) conducted by qualified technical personnel using calibrated equipment, not on expert clinical consensus or interpretation in the way a diagnostic imaging device might be evaluated.
Adjudication method for the test set:
- Not Applicable. As the "ground truth" is based on objective physical measurements, there's no need for an adjudication method involving multiple human reviewers.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a tanning lamp, which is an energy-delivering device, not a diagnostic or AI-powered device that involves "human readers" or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
The type of ground truth used:
- The "ground truth" was established through objective physical measurements and technical specifications of the lamps. This includes:
  - Electrical power requirements
  - Spectral output (in nm increments)
  - Energy output (UVA and UVB range)
  - Approximate lifetime
  - Physical dimensions and connector design
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no training set in that context. The device's characteristics are determined by its manufacturing, not by being "trained" on data.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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

April 2, 2015

Unilam Company, Ltd Ho Dong, Yang Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul, 135-768, South Korea

Re: K143043

Trade/Device Name: Tanning Lamp Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet lamp for tanning Regulatory Class: Class II Product Code: LEJ Dated: February 11, 2015 Received: February 25, 2015

Dear Mr. Yang:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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/ResourcesforYou/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.

Jennifer R. Stevenson -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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Indications for Use

510(k) Number (if known) K143043

Device Name Tanning Lamp

Indications for Use (Describe) Intended to provide ultraviolet light to tan the skin

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)

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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, UlsanUlsan Gwangyeogsi , 689-813, Republic of KoreaTel: +82-55-3722509
Contact Person:	Ho Dong, YangOnbix Corporation#821 Samil Plaza, 837-26 Yeuksam-dongGangnam-gu, Seoul, 135,768, KoreaTel: +82-2-566-3360 / Fax: +82-2-6280-3360Email: onbix@naver.com
Date Summary Prepared:	Apr 02. 2015

Device Information:

Trade Name(s): Classification Name: Panel: Product code:

Tanning Lamp Ultraviolet lamp for tanning general & plastic surgery LEJ

Predicate Device Information:

NARVA LICHTQUELLEN GMBH + CO KG (Registration number: 3003994709)

Device Description:

Tanning lamp is electronic products to be intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths to induce skin tanning.

Intended Use:

Intended to provide ultraviolet light to tan the skin

Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

- indications for use
- technological characteristics
- performance properties

Summary of the technological characteristics compared to the predicate device

new device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below

Comparison table is as follows

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Features	New device	Predicate device
manufacturer	Unilam Co., Ltd.	NARVA LICHTQUELLENGMBH + CO KG
Registrationnumber	3007123863	3003994709
Product code	LEJ	LEJ
Product name	Unilam Tanning Lamp	Cosmedico Light Inc.
Intended use	Intended to provide ultravioletlight to tan the skin	Intended to provide ultraviolet light totan the skin
sterilization	Not applicable	Not applicable
Power source	Ballast Cosmedico #74427(input 220V/60Hz)	Ballast Cosmedico #74427(input 220V/60Hz)
Technicalcharacteristic	Radiate UVA(315~~400nm) andUVB(280~~315nm)The UVC is cutby the quartz bulb.	Radiate UVA(315~~400nm) andUVB(280~~315nm)The UVC is cutby the quartz bulb.
frequency	60Hz	60Hz
Device model	various	various

Non-Clinical Study performance

Performance studies were conducted comparing the Unilam UV lamps to the predicate Cosmedico UV lamps. These studies included electrical power requirements for lamp activation, lamp spectral output and lamp energy output. Specifically the company prepared individual test data sheets that include an illustration of the output spectra of the bulbs in nm increments, the energy output for each bulb in the UVA and UVB range, the approximate lifetime of the bulbs, a description of the individual bulb dimensions and an illustration of the unique connector design for the individual bulbs. This information was prepared to the Unilam bulbs and the Cosmedico predicate bulbs. Tables were provided comparing the wavelength range and UVA and UVB output energies for Unilam compared to Cosmedico.

Conclusion

Based on the information provided in this summary we conclude that Unilam Tanning Lamp is safe and effective and substantially equivalent to the NARVA LICHTQUELLEN GMBH + CO KG

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.