Clearance Summary
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) received FDA 510(k) clearance under submission number K013756, sponsored by Argus Biomedical Pty, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-08-29.
- Submission: K013756
- Applicant / Sponsor: Argus Biomedical Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3400
- Decision date: 2002-08-29
Classification & Regulation
This clearance is catalogued under FDA product code HQM and 21 CFR 886.3400, within the Ophthalmic review panel as a Class II device.