CT LUCIA Intraocular lens (Model 611P)
FDA premarket approval P100016/S008 · decided 2021-07-08
Approval details
- PMA number
- P100016
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CT LUCIA Intraocular lens (Model 611P)
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2020-09-08
- Decision date
- 2021-07-08
- Days to decision
- 303 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for a new product model, CT LUCIA 611P, which is a design change to product CT LUCIA 602.
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