The following data is part of a premarket notification filed by Surgilight, Inc. with the FDA for Surgilight, Inc Excimer Laser.
| Device ID | K993328 |
| 510k Number | K993328 |
| Device Name: | SURGILIGHT, INC EXCIMER LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGILIGHT, INC. 12001 SCIENCE DR., SUITE 140 Orlando, FL 32826 |
| Contact | Timothy J Shea |
| Correspondent | Timothy J 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 | 1999-10-04 |
| Decision Date | 2000-07-18 |
| Summary: | summary |