The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visulas Trion.
| Device ID | K072514 |
| 510k Number | K072514 |
| Device Name: | VISULAS TRION |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CARL ZEISS MEDITEC AG 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Kent W Jones |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471091229 | K072514 | 000 |