The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Visulas Argon Laser.
Device ID | K923341 |
510k Number | K923341 |
Device Name: | ZEISS VISULAS ARGON LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
Contact | Christopher Talbot |
Correspondent | Christopher Talbot CARL ZEISS, INC. 305 COLLEGE RD. EAST Princeton, NJ 08540 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-05 |
Decision Date | 1992-10-28 |