Cleared Traditional

CryoTreQ

K202038 · Vitreq BV · Ophthalmic

Dec 2020

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K202038 is an FDA 510(k) clearance for the CryoTreQ, a Unit, Cryophthalmic (Class II — Special Controls, product code HPS), submitted by Vitreq BV (Vierpolders, NL). The FDA issued a Cleared decision on December 30, 2020, 160 days after receiving the submission on July 23, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number	K202038 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2020
Decision Date	December 30, 2020
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF