The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Zeiss Opmilas 144 Surgical Lasers.
| Device ID | K942439 |
| 510k Number | K942439 |
| Device Name: | ZEISS OPMILAS 144 SURGICAL LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ZEISS HUMPHREY SYSTEM 2992 ALVARADO ST. P.O. BOX 5400 San Leandro, CA 94577 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot ZEISS HUMPHREY SYSTEM 2992 ALVARADO ST. P.O. BOX 5400 San Leandro, CA 94577 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-11 |
| Decision Date | 1994-07-01 |