Cleared Traditional

K123031 - BWF-5 MEDICAL LASER SERIES

K123031 is an FDA 510(k) clearance for BWF-5 MEDICAL LASER SERIES, manufactured by Litecure, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K123031 · Litecure, LLC · General & Plastic Surgery device
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Dec 2012
Decision
66d
Days
Class 2
Risk

K123031 is an FDA 510(k) clearance for the BWF-5 MEDICAL LASER SERIES. 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 Litecure, LLC (Newark, US). The FDA issued a Cleared decision on December 3, 2012 after a review of 66 days - a notably fast clearance 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: 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 Litecure, LLC devices

FDA 510(k) Submission Details - K123031

510(k) Number K123031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date December 03, 2012
Days to Decision 66 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
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 1598
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K123031.
VITRA MULTISPOT
K122251 · Quantel Medical · Jan 2013
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K123168 · Quanta System Spa · Dec 2012
MEDILAS H LASER FIBERS
K123385 · Dornier Medtech America, Inc. · Dec 2012
PICOSURE WORKSTATION
K121346 · Cynosure, Inc. · Nov 2012
EPIC 10
K121286 · Biolase Technology, Inc. · Sep 2012
PRECISE SHP DIODE LASER
K113472 · CAO Group, Inc. · Aug 2012