Clearance Summary
DURETTE OCULAR IMPLANT received FDA 510(k) clearance under submission number K123764, sponsored by Oculo-Plastik, 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 2013-01-31.
- Submission: K123764
- Applicant / Sponsor: Oculo-Plastik, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3320
- Decision date: 2013-01-31
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.