Cleared Traditional

K182741 - SculpSure

K182741 is the FDA 510(k) clearance for SculpSure by Cynosure. It is a Class 2 General & Plastic Surgery device (product code PKT) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K182741 · Cynosure · General & Plastic Surgery device
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Jan 2019
Decision
97d
Days
Class 2
Risk

K182741 is an FDA 510(k) clearance for the SculpSure. Classified as Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT), Class II - Special Controls.

Submitted by Cynosure (Wesford, US). The FDA issued a Cleared decision on January 3, 2019 after a review of 97 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cynosure devices

Submission Details

510(k) Number K182741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date January 03, 2019
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use

All 18
Devices cleared under the same product code (PKT) and FDA review panel - the closest regulatory comparables to K182741.
Diode Laser Body Sculpture System
K201731 · Shanghai Apolo Medical Technology Co., Ltd. · Sep 2020
Powersculp laser lipolysis system
K191068 · Wuhan Lotuxs Technology Co., Ltd. · Jul 2019
Eon FR
K180511 · Dominion Aesthetic Technologies, Inc. · Jun 2019
SculpSure
K171992 · Cynosure, Inc. · Sep 2017
Sculpsure
K171111 · Cynosure, Inc. · Jun 2017
SculpSure
K160470 · Cynosure, Inc. · Jul 2016