Cleared Traditional

SculpSure (K160470) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160470 · Cynosure, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
153d
Days
Class 2
Risk

K160470 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, Inc. (Wesford, US). The FDA issued a Cleared decision on July 21, 2016 after a review of 153 days - an extended review cycle.

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, Inc. devices

Submission Details

510(k) Number K160470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date July 21, 2016
Days to Decision 153 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
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 K160470.
1060nm laser body slimming machine
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ReBorn (1050nm)
K233962 · Lightfective , Ltd. · Apr 2024
DEKA PHYSIQ 360
K231971 · El.En S.P.A. · Sep 2023
Diode Laser Body Sculpture Systems
K231131 · Shanghai Bele Medical Technology Co.,Ltd · Jun 2023
EON
K222226 · Dominion Aesthetic Technologies, Inc. · Feb 2023
Diosculpt
K222265 · Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd · Sep 2022