Cleared Traditional

K043012 - OMNIPULSE MINI

K043012 is an FDA 510(k) clearance for OMNIPULSE MINI, manufactured by Trimedyne, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K043012 · Trimedyne, Inc. · General & Plastic Surgery device
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Nov 2004
Decision
15d
Days
Class 2
Risk

K043012 is an FDA 510(k) clearance for the OMNIPULSE MINI, MODEL 2120. 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 Trimedyne, Inc. (Irvine, US). The FDA issued a Cleared decision on November 17, 2004 after a review of 15 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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K043012

510(k) Number K043012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2004
Decision Date November 17, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
ELIZABETH DREW

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 1566
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K043012.
MCL 30 DERMABLATE ER:YAG LASER SYSTEM
K042968 · Asclepion Laser Technologies GmbH · Nov 2004
CANDELA SMOOTHBEAM LASER SYSTEM
K041242 · Candela Corp. · Nov 2004
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
K041323 · New Star Lasers, Inc. · Nov 2004
POLARIS DS/COMET
K041959 · Syneron Medical, Ltd. · Nov 2004
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
K042211 · Surgical Laser Technologies, Inc. · Nov 2004
AURORA DS
K041969 · Syneron Medical, Ltd. · Oct 2004

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.