Cleared Traditional

SculpSure

K150724 · Cynosure, Inc. · General & Plastic Surgery

Jul 2015

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K150724 is an FDA 510(k) clearance for the SculpSure, a Laser For Disruption Of Adipocyte Cells For Aesthetic Use (Class II — Special Controls, product code PKT), submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on July 1, 2015, 103 days after receiving the submission on March 20, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number	K150724 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2015
Decision Date	July 01, 2015
Days to Decision	103 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5400
Definition	Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.