Cleared Special

ASA 'MPHI FAMILY DIODE LASER

K111901 · Cynosure, Inc. · Physical Medicine
Nov 2011
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K111901 is an FDA 510(k) clearance for the ASA 'MPHI FAMILY 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 November 9, 2011, 127 days after receiving the submission on July 5, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number K111901 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2011
Decision Date November 09, 2011
Days to Decision 127 days
Submission Type Special
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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