POSTERIOR CHAMBER INTROCULAR LENSES
FDA premarket approval P830056/S077 · decided 1996-08-01
Approval details
- PMA number
- P830056
- Supplement
- S077
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POSTERIOR CHAMBER INTROCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec, AG
- Date received
- 1996-05-31
- Decision date
- 1996-08-01
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CARIBE, LOT 2 JIBARO INDUSTRIAL PARK, CIDRA, PR 00639
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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 |