Cleared Traditional

OPTIMUS FUSION: SLT, YAG AND YAG/SLT

K140336 · Quantel Medical · Ophthalmic
Jun 2014
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K140336 is an FDA 510(k) clearance for the OPTIMUS FUSION: SLT, YAG AND YAG/SLT, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (North Reading, US). The FDA issued a Cleared decision on June 25, 2014, 135 days after receiving the submission on February 10, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K140336 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2014
Decision Date June 25, 2014
Days to Decision 135 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