Cleared Traditional

Frigitronics adapter

K180195 · Phakos · Ophthalmic
Mar 2018
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K180195 is an FDA 510(k) clearance for the Frigitronics adapter, a Unit, Cryophthalmic, Ac-powered (Class II — Special Controls, product code HRN), submitted by Phakos (Montreuil, FR). The FDA issued a Cleared decision on March 16, 2018, 51 days after receiving the submission on January 24, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K180195 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2018
Decision Date March 16, 2018
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HRN — Unit, Cryophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170

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