Cleared Traditional

CYNOSURE 1064NM DIODE LASER

K123971 · Cynosure, Inc. · Physical Medicine
May 2013
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K123971 is an FDA 510(k) clearance for the CYNOSURE 1064NM DIODE LASER, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on May 2, 2013, 127 days after receiving the submission on December 26, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number K123971 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date May 02, 2013
Days to Decision 127 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ILY — Lamp, Infrared, Therapeutic Heating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5500

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