CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P
FDA premarket approval P100016/S022 · decided 2025-08-20
Approval details
- PMA number
- P100016
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2025-07-25
- Decision date
- 2025-08-20
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- adding two alternative raw materials suppliers
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