Cleared Traditional

MIRA Adapter

K200911 · Phakos · Ophthalmic
Jun 2020
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K200911 is an FDA 510(k) clearance for the MIRA 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 June 2, 2020, 57 days after receiving the submission on April 6, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K200911 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2020
Decision Date June 02, 2020
Days to Decision 57 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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