Clearance Summary
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers received FDA 510(k) clearance under submission number K220263, sponsored by Vortex Surgical, 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 2022-11-03.
- Submission: K220263
- Applicant / Sponsor: Vortex Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4690
- Decision date: 2022-11-03
Classification & Regulation
This clearance is catalogued under FDA product code HQB and 21 CFR 886.4690, within the Ophthalmic review panel as a Class II device.