Cleared Traditional

Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

K220263 · Vortex Surgical, Inc. · Ophthalmic

Nov 2022

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K220263 is an FDA 510(k) clearance for the Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by Vortex Surgical, Inc. (Chesterfield, US). The FDA issued a Cleared decision on November 3, 2022, 276 days after receiving the submission on January 31, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number	K220263 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2022
Decision Date	November 03, 2022
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF