The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Optilase Yag Model 1000 Surgical Laser System.
Device ID | K894977 |
510k Number | K894977 |
Device Name: | OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
Contact | Merritt M Girgis |
Correspondent | Merritt M Girgis TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-07 |
Decision Date | 1989-10-10 |