Cleared Traditional

MAXReach Laser Probe

K191846 · Vortex Surgical, Inc. · Ophthalmic

Dec 2019

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K191846 is an FDA 510(k) clearance for the MAXReach Laser Probe, 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 December 23, 2019, 166 days after receiving the submission on July 10, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number	K191846 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2019
Decision Date	December 23, 2019
Days to Decision	166 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF