Cleared Traditional

Diode Laser Body Sculpture System (K201731) - FDA 510(k) Clearance

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

K201731 · Shanghai Apolo Medical Technology Co., Ltd. · General & Plastic Surgery device
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Sep 2020
Decision
78d
Days
Class 2
Risk

K201731 is an FDA 510(k) clearance for the Diode Laser Body Sculpture System. Classified as Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT), Class II - Special Controls.

Submitted by Shanghai Apolo Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 10, 2020 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Apolo Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K201731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2020
Decision Date September 10, 2020
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 15
Devices cleared under the same product code (PKT) and FDA review panel - the closest regulatory comparables to K201731.
BodySculp
K212331 · Rohrer Aesthetics, LLC · Nov 2021
Powersculp laser lipolysis system
K211402 · Lotuxs Medtech (Suzhou) Co., Ltd. · Jul 2021
SLIMUS
K192970 · Hironic Co., Ltd. · Dec 2020
Powersculp laser lipolysis system
K191068 · Wuhan Lotuxs Technology Co., Ltd. · Jul 2019
Eon FR
K180511 · Dominion Aesthetic Technologies, Inc. · Jun 2019
SculpSure
K182741 · Cynosure · Jan 2019