Cleared Special

K030959 - BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100

K030959 is an FDA 510(k) clearance for BARE LASER FIBER MODELS DBLF-40, manufactured by Laser Peripherals, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 29-day FDA review.

K030959 · Laser Peripherals, LLC · General & Plastic Surgery device
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Apr 2003
Decision
29d
Days
Class 2
Risk

K030959 is an FDA 510(k) clearance for the BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF.... 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 Laser Peripherals, LLC (Golden Valley, US). The FDA issued a Cleared decision on April 25, 2003 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030959

510(k) Number K030959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2003
Decision Date April 25, 2003
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 2668
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K030959.
DEPILASE YAG LASE PLUS LASER SYSTEM
K030506 · Depilase Group , Ltd. · May 2003
SMARTXIDE
K031224 · Cynosure, Inc. · May 2003
ARAMIS II DERMATOLOGICAL LASER
K023734 · Quantel Medical · May 2003
F1 DIODE LASER SYSTEM
K030235 · Opus Medical, Inc. · Apr 2003
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
K030181 · International Biophysics Corp. · Apr 2003
DIOLASE 980 D LASER SYSTEM
K023547 · American Dental Technologies, Inc. · Apr 2003