Cleared Traditional

K182924 - Diode Laser Treatment System (FDA 510(k) Clearance)

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

K182924 · Weifang KM Electronics Co., Ltd. · General & Plastic Surgery device
Apr 2019
Decision
178d
Days
Class 2
Risk

K182924 is an FDA 510(k) clearance for the Diode Laser Treatment System. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Weifang KM Electronics Co., Ltd. (Weifang, CN). The FDA issued a Cleared decision on April 15, 2019 after a review of 178 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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.

Submission Details

510(k) Number K182924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2018
Decision Date April 15, 2019
Days to Decision 178 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 132d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 127
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K182924.
CO2 Laser System
K260257 · Sanhe Meditech Co., Ltd. · Mar 2026
LASER THERMAL THERAPY KIT
K260632 · Elesta S.P.A · Mar 2026
Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
K252971 · C.R. Bard, Inc. · Mar 2026
Picasso Pro Diode Laser (002-00460)
K254197 · CAO Group, Inc. · Mar 2026
Holmium Laser Therapeutic Apparatus (HZ-A)
K253951 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Mar 2026
CO2 Laser Treatment Machine (CFR3M1)
K253920 · Haidari?Beauty?Technology?(Beijing)?Co.,?, Ltd. · Mar 2026