The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Iolmaster.
| Device ID | K993357 |
| 510k Number | K993357 |
| Device Name: | IOLMASTER |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Scott A Margolin |
| Correspondent | Scott A Margolin CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-06 |
| Decision Date | 2000-03-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IOLMASTER 75608402 2447354 Live/Registered |
CARL ZEISS AG 1998-12-22 |