CT LUCIA 202 and CT LUCIA 602 intraocular lenses
FDA premarket approval P100016/S006 · decided 2018-09-20
Approval details
- PMA number
- P100016
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CT LUCIA 202 and CT LUCIA 602 intraocular lenses
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2018-08-24
- Decision date
- 2018-09-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Add an alternative machine for lens haptic hole drilling for the CT LUCIA 202 and CT LUCIA 602 intraocular lenses.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.