The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visulas Yag Iii.
| Device ID | K042139 |
| 510k Number | K042139 |
| Device Name: | VISULAS YAG III |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 -7562 |
| Contact | R. Michael Crompton |
| Correspondent | R. Michael Crompton CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 -7562 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471091373 | K042139 | 000 |