Data / Medical devices / Light, Ultraviolet, Dermatological
Light, Ultraviolet, Dermatological (FTC): 21 FDA-registered makers in 8 countries
21 establishments in 8 countries are registered with the FDA to make Light, Ultraviolet, Dermatological (product code FTC, Class 2, 21 CFR 878.4630). 18 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 274 510(k) clearances under this code, the latest on October 14, 2026, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FTC
- Device class
- 2
- Regulation
- 878.4630
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 8 |
| United States | 7 |
| Canada | 1 |
| Israel | 1 |
| France | 1 |
| Netherlands | 1 |
| Germany | 1 |
| Mexico | 1 |
Makers of Light, Ultraviolet, Dermatological
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| The Daavlin Distributing Co. | Bryan, OH, United States | Complaint file establishment, Manufacturer | 24 | December 13, 2023 | 0 | 4 | 0 | api.fda.gov |
| Medtek Skin Care, Inc. | Hudson Falls, NY, United States | Manufacturer | 7 | October 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Solarc Systems Inc. | MINESING Ontario, Canada | Manufacturer | 4 | April 27, 2011 | 0 | 0 | 0 | api.fda.gov |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou Jiangsu, China | Manufacturer | 4 | February 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alma Lasers Ltd. | CAESAREA Northern, Israel | Manufacturer | 2 | December 26, 2007 | 0 | 0 | 0 | api.fda.gov |
| Clarteis | Vallauris Alpes-Maritimes, France | Manufacturer | 2 | December 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Psoria-Shield Inc | Utica, NY, United States | Manufacturer | 2 | March 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ultrasun | HENGELO Overijssel, Netherlands | Manufacturer | 2 | December 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Apk Technology Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 1 | April 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Chongqing Peninsula Medical Technology Co., Ltd. | Chongqing, China | Manufacturer | 1 | July 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| German Medical Engineering GMBH | Erlangen Bavaria, Germany | Manufacturer | 1 | July 31, 2015 | 0 | 0 | 0 | api.fda.gov |
| KBD, Inc. | North Las Vegas, NV, United States | Specification developer | 1 | August 6, 1986 | 0 | 0 | 0 | api.fda.gov |
| Radcliffe Watts, LLC | Mansfield, OH, United States | Complaint file establishment, Specification developer | 1 | March 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Sigma High-Tech Co., Ltd. | Shanghai, China | Manufacturer | 1 | December 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen GSD Tech Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | December 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Peninsula Medical Group | Shenzhen Guangdong, China | Manufacturer | 1 | March 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd | Xuzhou Jiangsu, China | Manufacturer | 1 | February 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zerigo Health, Inc. | Carlsbad, CA, United States | Specification developer | 1 | May 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Global Fabtech Wheel Chair (shanghai) Co., Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Assembly Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.