The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Visulas Green.
| Device ID | K181682 |
| 510k Number | K181682 |
| Device Name: | VISULAS Green |
| Classification | Laser, Ophthalmic |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE 07445 |
| Contact | Christian Munster |
| Correspondent | Lisa Graney Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-26 |
| Decision Date | 2019-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049471091441 | K181682 | 000 |
| 04049471091434 | K181682 | 000 |
| 04049471091427 | K181682 | 000 |
| 04049471091410 | K181682 | 000 |