TL100W/01 Uvb Lamp
FDA 510(k) K910767 · Philips Lighting Co.
510(k) numberK910767
Submission
- Device name
- TL100W/01 Uvb Lamp
- Applicant
- Philips Lighting Co.
Somerset, NJ, US - Received
- February 22, 1991
- Decision date
- May 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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More from Psoria-Shield, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130519 | Philips Uva (/09) and Philips UVA-1 (/10) Ultraviolet LampsFTC · Traditional | 12/24/2013SE |
| K021514 | Philips PLS9W/12/2P UvbFTC · Traditional | 05/16/2002SE |
| K021092 | Philips TL 20W/01RS Uv-B, Philips Pl-S 9W/01/2P UV, and Philips Pl-L 36W/01/4P Uv-BFTC · Traditional | 05/16/2002SE |
| K940672 | Cleo TL80W Professional Cleo TL80W Professional R, Cleo TL100 W ProfessionalLEJ · Traditional | 03/18/1994SE |
| K935840 | TL 20W/12/RS & TL 40W/12/RSFTC · Traditional | 02/24/1994SE |
| K922963 | TL100W/12FTC · Traditional | 09/02/1992SE |
Questions and answers
When was TL100W/01 Uvb Lamp cleared by the FDA?
TL100W/01 Uvb Lamp (K910767) received a 510(k) decision of Substantially Equivalent on May 23, 1991, 90 days after the submission was received.
What is the product code of K910767?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.