Clearance Summary
ZEPTO Precision Capsulotomy System received FDA 510(k) clearance under submission number K210827, sponsored by Centricity Vision, 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 2021-12-14.
- Submission: K210827
- Applicant / Sponsor: Centricity Vision, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4100
- Decision date: 2021-12-14
Classification & Regulation
This clearance is catalogued under FDA product code PUL and 21 CFR 886.4100, within the Ophthalmic review panel as a Class II device.