CT LUCIA Intraocular Lens (IOL)
FDA premarket approval P100016/S015 · decided 2023-01-05
Approval details
- PMA number
- P100016
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CT LUCIA Intraocular Lens (IOL)
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2022-12-09
- Decision date
- 2023-01-05
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Changing to an automated extraction system used in hydrophobic button production of CT Lucia 602, CT Lucia 202, and CT Lucia 611P intraocular lens.
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