Cleared Traditional

ILUMINAGE DIODE LASER

K111454 · Cynosure, Inc. · General & Plastic Surgery

Jul 2012

Decision

407d

Days

Class 2

Risk

About This 510(k) Submission

K111454 is an FDA 510(k) clearance for the ILUMINAGE DIODE LASER, a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on July 5, 2012, 407 days after receiving the submission on May 25, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K111454 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 2011
Decision Date	July 05, 2012
Days to Decision	407 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHS — Light Based Over The Counter Wrinkle Reduction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.