Cleared Traditional

K191068 - Powersculp laser lipolysis system (FDA 510(k) Clearance)

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

K191068 · Wuhan Lotuxs Technology Co., Ltd. · General & Plastic Surgery device
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Jul 2019
Decision
86d
Days
Class 2
Risk

K191068 is an FDA 510(k) clearance for the Powersculp laser lipolysis system. Classified as Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT), Class II - Special Controls.

Submitted by Wuhan Lotuxs Technology Co., Ltd. (East Lake High-Tech Development Zone, Wu, CN). The FDA issued a Cleared decision on July 17, 2019 after a review of 86 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 Wuhan Lotuxs Technology Co., Ltd. devices

Submission Details

510(k) Number K191068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2019
Decision Date July 17, 2019
Days to Decision 86 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
28d faster than avg
Panel avg: 114d · This submission: 86d
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
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