MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES
FDA premarket approval P830056/S079 · decided 1999-05-11
Approval details
- PMA number
- P830056
- Supplement
- S079
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec, AG
- Date received
- 1998-11-12
- Decision date
- 1999-05-11
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- Approval for posterior chamber intraocular lens models C451F, C421F, and C455A5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
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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 |