Clearance Summary
AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR received FDA 510(k) clearance under submission number K930320, sponsored by Allergan Medical Optics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-04-07.
- Submission: K930320
- Applicant / Sponsor: Allergan Medical Optics
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 1994-04-07
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.