Cleared Traditional

K131837 - CO2 FRACTIONAL LASER

K131837 is an FDA 510(k) clearance for CO2 FRACTIONAL LASER, manufactured by Beijing Honkon Technologies Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K131837 · Beijing Honkon Technologies Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
216d
Days
Class 2
Risk

K131837 is an FDA 510(k) clearance for the CO2 FRACTIONAL LASER. 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 Beijing Honkon Technologies Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on January 22, 2014 after a review of 216 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.

View all Beijing Honkon Technologies Co., Ltd. devices

FDA 510(k) Submission Details - K131837

510(k) Number K131837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2013
Decision Date January 22, 2014
Days to Decision 216 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
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 1681
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K131837.
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
K133319 · Lumenis, Ltd. · Mar 2014
LUMENIS PULSE 120H
K140388 · Lumenis, Ltd. · Mar 2014
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
K133254 · Cynosure, Inc. · Mar 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
K133283 · Candela Corp. · Dec 2013
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
K133561 · AngioDynamics, Inc. · Dec 2013
FAMILY OF COOLGLIDE AESTHETIC LASERS
K132185 · Cutera, Inc. · Dec 2013