Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
FTC
Device class
2
Regulation
878.4630
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China8
United States7
Canada1
Israel1
France1
Netherlands1
Germany1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
The Daavlin Distributing Co.Bryan, OH, United StatesComplaint file establishment, Manufacturer24December 13, 2023040api.fda.gov
Medtek Skin Care, Inc.Hudson Falls, NY, United StatesManufacturer7October 15, 2014000api.fda.gov
Solarc Systems Inc.MINESING Ontario, CanadaManufacturer4April 27, 2011000api.fda.gov
Xuzhou Kernel Medical Equipment Co LtdXuzhou Jiangsu, ChinaManufacturer4February 6, 2025000api.fda.gov
Alma Lasers Ltd.CAESAREA Northern, IsraelManufacturer2December 26, 2007000api.fda.gov
ClarteisVallauris Alpes-Maritimes, FranceManufacturer2December 11, 2019000api.fda.gov
Psoria-Shield IncUtica, NY, United StatesManufacturer2March 8, 2023000api.fda.gov
UltrasunHENGELO Overijssel, NetherlandsManufacturer2December 10, 2021000api.fda.gov
Apk Technology Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer1April 7, 2025000api.fda.gov
Chongqing Peninsula Medical Technology Co., Ltd.Chongqing, ChinaManufacturer1July 30, 2018000api.fda.gov
German Medical Engineering GMBHErlangen Bavaria, GermanyManufacturer1July 31, 2015000api.fda.gov
KBD, Inc.North Las Vegas, NV, United StatesSpecification developer1August 6, 1986000api.fda.gov
Radcliffe Watts, LLCMansfield, OH, United StatesComplaint file establishment, Specification developer1March 4, 2026000api.fda.gov
Shanghai Sigma High-Tech Co., Ltd.Shanghai, ChinaManufacturer1December 19, 2024000api.fda.gov
Shenzhen GSD Tech Co., LtdShenzhen Guangdong, ChinaManufacturer1December 15, 2020000api.fda.gov
Shenzhen Peninsula Medical GroupShenzhen Guangdong, ChinaManufacturer1March 13, 2025000api.fda.gov
Xuzhou Yongkang Electronic Science Technology Co., LtdXuzhou Jiangsu, ChinaManufacturer1February 6, 2020000api.fda.gov
Zerigo Health, Inc.Carlsbad, CA, United StatesSpecification developer1May 23, 2017000api.fda.gov
Global Fabtech Wheel Chair (shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Spectrum Assembly Inc.Carlsbad, CA, United StatesContract manufacturer0000api.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.