Clearance Summary
INTRAOCULAR LENS GUIDE received FDA 510(k) clearance under submission number K823222, sponsored by American 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 1982-12-28.
- Submission: K823222
- Applicant / Sponsor: American Medical Optics
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 1982-12-28
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.