Approval for the mel 80 excimer laser system. This device uses an optical zone of 6. 0 to 6. 5 mm in diameter and a transition zone of 2. 0 to 4. 0 mm for a total ablation diameter of 10. 0 mm, and is indicated for primary laser assisted in situ keratomileusis (lasik) treatments for: 1) the reduction or elimination of naturally-occurring hyperopia of less than or equal to +5. 0 d with or without refractive astigmatism of > +0. 5 and
| Device | MEDITEC MEL 80 EXCIMER LASER SYSTEM |
| Generic Name | Excimer Laser System |
| Applicant | Carl Zeiss Meditec, Inc. |
| Date Received | 2007-12-28 |
| Decision Date | 2011-03-28 |
| Notice Date | 2011-04-25 |
| PMA | P060004 |
| Supplement | S001 |
| Product Code | LZS |
| Docket Number | 11M-0256 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060004 | | Original Filing |
| S002 |
2008-01-18 |
30-day Notice |
| S001 |
2007-12-28 |
Panel Track |
NIH GUDID Devices