Cleared Traditional

MERILAS 532A

K072823 · Meridian AG · Ophthalmic
Dec 2007
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K072823 is an FDA 510(k) clearance for the MERILAS 532A, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Meridian AG (Littleton, US). The FDA issued a Cleared decision on December 14, 2007, 73 days after receiving the submission on October 2, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K072823 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2007
Decision Date December 14, 2007
Days to Decision 73 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