Cleared Special

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR

K070776 · Quantel Medical · Ophthalmic
Apr 2007
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K070776 is an FDA 510(k) clearance for the SUPRA 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 April 24, 2007, 34 days after receiving the submission on March 21, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K070776 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2007
Decision Date April 24, 2007
Days to Decision 34 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