The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Visulas 532s.
| Device ID | K013402 |
| 510k Number | K013402 |
| Device Name: | VISULAS 532S |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471091403 | K013402 | 000 |