Cleared Traditional

BWF-5 MEDICAL LASER SERIES (K093087) - FDA 510(k) Clearance

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

K093087 · Litecure, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
223d
Days
Class 2
Risk

K093087 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 May 12, 2010 after a review of 223 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 Litecure, LLC devices

Submission Details

510(k) Number K093087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date May 12, 2010
Days to Decision 223 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 115d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 633
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K093087.
FLEXIVA TRACTIP
K110685 · Boston Scientific Corp · Mar 2011
ACCUTRAC
K110686 · Boston Scientific Corp · Mar 2011
AFFIRM DO DIODE LASER
K101601 · Cynosure, Inc. · Sep 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · Boston Scientific Corp · Feb 2010
VARI-LASE ENDOVENOUS LASER CONSOLE
K093502 · Vascular Solutions, Inc. · Jan 2010
ACCUMAX
K093691 · Boston Scientific Corp · Dec 2009