Cleared Traditional

NAVILAS LASER SYSTEM

K091064 · Od-Os GmbH · Ophthalmic
Oct 2009
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K091064 is an FDA 510(k) clearance for the NAVILAS LASER SYSTEM, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Od-Os GmbH (Laguna Beach, US). The FDA issued a Cleared decision on October 27, 2009, 196 days after receiving the submission on April 14, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K091064 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2009
Decision Date October 27, 2009
Days to Decision 196 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