IC-8 Apthera Intraocular Lens (IOL)
FDA premarket approval P210005/S011 · decided 2025-08-04
Approval details
- PMA number
- P210005
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IC-8 Apthera Intraocular Lens (IOL)
- Generic name
- Extended depth of focus intraocular lens
- Applicant
- Acu Focus, Inc.
- Date received
- 2025-07-21
- Decision date
- 2025-08-04
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- POE
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- approval for a change to the address block of your labeling for the IC-8 Apthera IOL to align with other IOLs in the Bausch & Lomb portfolio
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