Cleared Traditional

SUPRA 577.Y LASER

K091581 · Quantel Medical · Ophthalmic
Jun 2009
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K091581 is an FDA 510(k) clearance for the SUPRA 577.Y LASER, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Quantel Medical (Clermont-Ferrand Cedex 2, FR). The FDA issued a Cleared decision on June 16, 2009, 14 days after receiving the submission on June 2, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K091581 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2009
Decision Date June 16, 2009
Days to Decision 14 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