Cleared Traditional

Easyret

K170067 · Quantel Medical · Ophthalmic
Jul 2017
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K170067 is an FDA 510(k) clearance for the Easyret, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (Cournon D'Auvergne-Cedex, FR). The FDA issued a Cleared decision on July 25, 2017, 197 days after receiving the submission on January 9, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K170067 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2017
Decision Date July 25, 2017
Days to Decision 197 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390