(162 days)
Not Found
Not Found
No
The summary describes a tanning lamp and its performance characteristics related to UV output and electrical properties, with no mention of AI or ML.
No
The device is described as being intended to "tan the skin" using ultraviolet light, which is a cosmetic purpose rather than a therapeutic one. Therapeutic devices are typically used for diagnosis, cure, mitigation, treatment, or prevention of disease, which is not indicated here.
No
The device is described as a tanning lamp intended for irradiating the human body with ultraviolet radiation to induce skin tanning. Its purpose is cosmetic/tanning, not to diagnose a disease, condition, or state of being. The performance studies also focus on electrical and light output characteristics, not diagnostic accuracy.
No
The device description explicitly states it is a "Tanning lamp" and describes physical components like "ultraviolet radiation with wavelengths" and "bulbs," indicating it is a hardware device. The performance studies also focus on physical characteristics like "electrical power requirements," "lamp spectral output," and "lamp energy output."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide ultraviolet light to tan the skin." This is a direct interaction with the living human body for a cosmetic purpose (skin tanning).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Lack of Specimen Analysis: The description of the device and its intended use does not involve the analysis of any biological specimens.
The device is a tanning lamp, which is a type of medical device that interacts with the body externally, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended to provide ultraviolet light to tan the skin
Product codes
LEJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
any part of the living human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
NARVA LICHTQUELLEN GMBH + CO KG
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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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3
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: +82-55-3722509 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul, 135,768, Korea
Tel: +82-2-566-3360 / Fax: +82-2-6280-3360
Email: 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 LICHTQUELLEN |
| GMBH + CO KG | ||
| Registration | ||
| number | 3007123863 | 3003994709 |
| Product code | LEJ | LEJ |
| Product name | Unilam Tanning Lamp | Cosmedico Light Inc. |
| Intended use | Intended to provide ultraviolet | |
| light to tan the skin | Intended to provide ultraviolet light to | |
| tan the skin | ||
| sterilization | Not applicable | Not applicable |
| Power source | Ballast Cosmedico #74427 | |
| (input 220V/60Hz) | Ballast Cosmedico #74427 | |
| (input 220V/60Hz) | ||
| Technical | ||
| characteristic | Radiate UVA(315~400nm) and | |
| UVB(280~315nm) | ||
| The UVC is cut | ||
| by the quartz bulb. | Radiate UVA(315~400nm) and | |
| UVB(280~315nm) | ||
| The UVC is cut | ||
| by 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