Cleared Traditional

K212331 - BodySculp (FDA 510(k) Clearance)

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

K212331 · Rohrer Aesthetics, LLC · General & Plastic Surgery device
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Nov 2021
Decision
105d
Days
Class 2
Risk

K212331 is an FDA 510(k) clearance for the BodySculp. Classified as Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT), Class II - Special Controls.

Submitted by Rohrer Aesthetics, LLC (Birmingham, US). The FDA issued a Cleared decision on November 9, 2021 after a review of 105 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 Rohrer Aesthetics, LLC devices

Submission Details

510(k) Number K212331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2021
Decision Date November 09, 2021
Days to Decision 105 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
9d faster than avg
Panel avg: 114d · This submission: 105d
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 K212331.
1060nm laser body slimming machine
K240658 · Hebei JT Medical Co., Ltd. · May 2024
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