The following data is part of a premarket notification filed by Lumenis with the FDA for Dermaclear Uv-b Phototherapy System.
| Device ID | K011197 |
| 510k Number | K011197 |
| Device Name: | DERMACLEAR UV-B PHOTOTHERAPY SYSTEM |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | LUMENIS 1249 QUARRY LN. SUITE 100 Pleasanton, CA 94566 -3403 |
| Contact | C. Robert Payne Jr. |
| Correspondent | C. Robert Payne Jr. LUMENIS 1249 QUARRY LN. SUITE 100 Pleasanton, CA 94566 -3403 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-12-14 |