ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
FDA premarket approval P990048 · decided 2000-04-12
Approval details
- PMA number
- P990048
- Trade name
- ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Carl Zeiss Meditec, AG
- Date received
- 1999-08-16
- Decision date
- 2000-04-12
- Days to decision
- 240 days
- Decision code
- APWD
- Product code
- MVF
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ZEISS CLINIC 360 (K260694) | Carl Zeiss Meditec, AG | 2026-07-17 |
| INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174) | Carl Zeiss Meditec, AG | 2025-01-10 |
| VISULAS combi (K233911) | Carl Zeiss Meditec, AG | 2024-09-06 |
| BLUE 400; BLUE 400 S (K240215) | Carl Zeiss Meditec, AG | 2024-06-28 |
| RESCAN 700 (K233421) | Carl Zeiss Meditec, AG | 2024-03-08 |
| CALLISTO eye (K232944) | Carl Zeiss Meditec, AG | 2023-12-21 |
| QEVO System (K232159) | Carl Zeiss Meditec, AG | 2023-09-21 |
| CALLISTO eye (K231676) | Carl Zeiss Meditec, AG | 2023-08-28 |