The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Opmilas Co2-l.
| Device ID | K894393 |
| 510k Number | K894393 |
| Device Name: | OPMILAS CO2-L |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Van Cader |
| Correspondent | Van Cader CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1989-07-27 |