Cleared Special

SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR

K081946 · Quantel Medical · Ophthalmic
Mar 2009
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K081946 is an FDA 510(k) clearance for the SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (Hasbrouck Heights, US). The FDA issued a Cleared decision on March 25, 2009, 260 days after receiving the submission on July 8, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K081946 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2008
Decision Date March 25, 2009
Days to Decision 260 days
Submission Type Special
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