POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)
FDA premarket approval P830056/S078 · decided 1998-01-29
Approval details
- PMA number
- P830056
- Supplement
- S078
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec, AG
- Date received
- 1996-07-23
- Decision date
- 1998-01-29
- Days to decision
- 555 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- Approval for lenses Models C440Z, U211M, UV91F, UV91F2, U691F, U691F2, C440U, C421F5, and C451F5. These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 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 |