The following data is part of a premarket notification filed by Surgilight, Inc. with the FDA for Ex-308 Excimer Laser For Phototherapy Treatment Of Vitiligo.
| Device ID | K020973 |
| 510k Number | K020973 |
| Device Name: | EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGILIGHT, INC. 12001 SCIENCE DR. SUITE 140 Orlando, FL 32826 |
| Contact | Timothy Shea |
| Correspondent | Timothy Shea SURGILIGHT, INC. 12001 SCIENCE DR. SUITE 140 Orlando, FL 32826 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-26 |
| Decision Date | 2002-03-29 |
| Summary: | summary |