Cleared Traditional

Sculpsure

K171111 · Cynosure, Inc. · General & Plastic Surgery

Jun 2017

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K171111 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. (Westford, US). The FDA issued a Cleared decision on June 13, 2017, 60 days after receiving the submission on April 14, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number	K171111 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 14, 2017
Decision Date	June 13, 2017
Days to Decision	60 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.