Clearance Summary
BIO-EYE II ORBITAL IMPLANT received FDA 510(k) clearance under submission number K003338, sponsored by Integrated Orbital Implants, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-02-07.
- Submission: K003338
- Applicant / Sponsor: Integrated Orbital Implants, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3320
- Decision date: 2001-02-07
Classification & Regulation
This clearance is catalogued under FDA product code HPZ and 21 CFR 886.3320, within the Ophthalmic review panel as a Class II device.