Aaris intraocular lens model EC-3 and EC-3 PAL
FDA premarket approval P100016/S003 · decided 2017-04-18
Approval details
- PMA number
- P100016
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aaris intraocular lens model EC-3 and EC-3 PAL
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2017-03-24
- Decision date
- 2017-04-18
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- Approval for a new cosmetic inspection requirement to detect and reject intraocular lenses with Flat Optic Aberration.
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