TL100W/12

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922963 ↗

FDA Product Code

FTC

Device Class

Class II

Regulation

21 CFR Part 878.4630

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cleo TL80W Professional Cleo TL80W Professional R, Cleo TL100 W Professional

  Class II

  FDA 510(k) K940672 Active Cleared 18 Mar 1994

• Tl 20W/12/Rs & Tl 40W/12/Rs

  Class II

  FDA 510(k) K935840 Active Cleared 24 Feb 1994

• Philips Tl 20W/01RS UV-B, Philips Pl-S 9W/01/2P UV, and Philips Pl-L 36W/01/4P UV-B

  Class II

  FDA 510(k) K021092 Active Cleared 16 May 2002

• TL100W/01 Uvb Lamp

  Class II

  FDA 510(k) K910767 Active Cleared 23 May 1991

• Philips Uva (/09) and Philips Uva-1 (/10) Ultraviolet Lamps

  Class II

  FDA 510(k) K130519 Active Cleared 24 Dec 2013

• Philips PLS9W/12/2P Uvb

  Class II

  FDA 510(k) K021514 Active Cleared 16 May 2002

• What is the TL100W/12 device used for?

  The TL100W/12 is a UVB broadband dermatological light device designed specifically for use in general and plastic surgery applications. It emits ultraviolet B light for therapeutic purposes in these medical fields.

• Is the TL100W/12 a single-use device or can it be reused?

  The device is not specified as single-use or reusable in the provided information. This detail would need to be confirmed through the manufacturer's instructions for use or product documentation.

• What regulatory status does the TL100W/12 have?

  The TL100W/12 is FDA 510(k) cleared with device class 2. It received clearance through the traditional pathway with a decision code of SESE (Substantially Equivalent) on September 2, 1992.

• What are the specifications of the TL100W/12?

  The TL100W/12 is a UVB broadband dermatological light device. It is manufactured by Philips Lighting Co. and has a product code of FTC. The device is designed for general and plastic surgery applications, though specific measurements or technical details beyond this are not provided.