PMA P210005S010
- Device
- IC-8 Apthera Intraocular Lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S010
- Product code
- POE
- Decision date
- 2026-07-14
- Classification
- Ophthalmic
- Generic name
- Extended depth of focus intraocular lens
- Approval order statement
- approval for continuing to conduct the PAS2 study under the currently approved protocol, SAIL-101-PAS2 Protocol Version 3.2, as approved under P210005/S004
Current openFDA PMA Record#
- Device
- IC-8 Apthera Intraocular Lens (IOL)
- Applicant
- Acu Focus, Inc.
- PMA number
- P210005
- Supplement
- S010
- Product code
- POE
- Generic name
- Extended depth of focus intraocular lens
- Decision date
- 2026-07-14
- Decision code
- APPR
- Date received
- 2025-05-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval for continuing to conduct the PAS2 study under the currently approved protocol, SAIL-101-PAS2 Protocol Version 3.2, as approved under P210005/S004