Cleared Traditional

K922375 - EXCEL DUOPULSE MODEL 3000 COMBINATION H...

K922375 is the FDA 510(k) clearance for EXCEL DUOPULSE MODEL 3000 COMBINATION H... by Excel Tech. , Ltd.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K922375 · Excel Tech. , Ltd. · General & Plastic Surgery device
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Jul 1992
Decision
49d
Days
Class 2
Risk

K922375 is an FDA 510(k) clearance for the EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG. 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 Excel Tech. , Ltd. (Holbrook, US). The FDA issued a Cleared decision on July 8, 1992 after a review of 49 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K922375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date July 08, 1992
Days to Decision 49 days
Submission Type Traditional
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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1170
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K922375.
SLT LASER DELIVERY SYSTEM
K922634 · Surgical Laser Technologies, Inc. · Jul 1992
ZEISS MULTI YAG LASER
K920967 · Carl Zeiss, Inc. · Jul 1992
CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER
K921842 · Cynosure, Inc. · Jul 1992
LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER
K921380 · Laserscope · Jun 1992
EXCEL DUOPAULSE MODEL 2000
K915679 · Excel Tech. , Ltd. · Jun 1992
ULTRALINE STERILE DISPOSABLE FIBER
K921807 · Heraeus Lasersonics, Inc. · Jun 1992