Cleared Traditional

Vitreq disposable laser probes, light fibers and Chandelier

K182646 · Vitreq BV · Ophthalmic

May 2019

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K182646 is an FDA 510(k) clearance for the Vitreq disposable laser probes, light fibers and Chandelier, a Photocoagulator And Accessories (Class II — Special Controls, product code HQB), submitted by Vitreq BV (Vierpolders, NL). The FDA issued a Cleared decision on May 1, 2019, 219 days after receiving the submission on September 24, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4690.

Submission Details

510(k) Number	K182646 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2018
Decision Date	May 01, 2019
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF