Tanning Lamp

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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 {1}------------------------------------------------ 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). 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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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 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. {4}------------------------------------------------ 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 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. {5}------------------------------------------------ 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.