Cleared Traditional

SUPRA SCAN DELIVERY SYSTEM

K120825 · Quantel Medical · Ophthalmic
Sep 2012
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K120825 is an FDA 510(k) clearance for the SUPRA SCAN DELIVERY SYSTEM, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (North Reading, US). The FDA issued a Cleared decision on September 14, 2012, 179 days after receiving the submission on March 19, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K120825 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2012
Decision Date September 14, 2012
Days to Decision 179 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