Cleared Traditional

K915679 - EXCEL DUOPAULSE MODEL 2000

K915679 is the FDA 510(k) clearance for EXCEL DUOPAULSE MODEL 2000 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 188-day FDA review.

K915679 · Excel Tech. , Ltd. · General & Plastic Surgery device
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Jun 1992
Decision
188d
Days
Class 2
Risk

K915679 is an FDA 510(k) clearance for the EXCEL DUOPAULSE MODEL 2000. 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 June 24, 1992 after a review of 188 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K915679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1991
Decision Date June 24, 1992
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
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 K915679.
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K921842 · Cynosure, Inc. · Jul 1992
EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG
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K921807 · Heraeus Lasersonics, Inc. · Jun 1992
ND
K915578 · Heraeus Lasersonics, Inc. · Jun 1992
SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40
K921146 · Sharplan Lasers, Inc. · Jun 1992