Cleared Traditional

NEXT GENERATION LASER

K062624 · Alcon Laboratories · Ophthalmic
Nov 2007
Decision
426d
Days
Class 2
Risk

About This 510(k) Submission

K062624 is an FDA 510(k) clearance for the NEXT GENERATION LASER, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on November 5, 2007, 426 days after receiving the submission on September 5, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K062624 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2006
Decision Date November 05, 2007
Days to Decision 426 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