Clearance Summary
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens received FDA 510(k) clearance under submission number K151961, sponsored by Volk Optical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-08-18.
- Submission: K151961
- Applicant / Sponsor: Volk Optical, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1385
- Decision date: 2015-08-18
Classification & Regulation
This clearance is catalogued under FDA product code HJK and 21 CFR 886.1385, within the Ophthalmic review panel as a Class II device.