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 |