Cleared Traditional

K092860 - LASEMAR 800, 1000, 1500

K092860 is an FDA 510(k) clearance for LASEMAR 800, manufactured by Eufoton S.R.L.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K092860 · Eufoton S.R.L. · General & Plastic Surgery device
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Jul 2010
Decision
302d
Days
Class 2
Risk

K092860 is an FDA 510(k) clearance for the LASEMAR 800, 1000, 1500. 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 Eufoton S.R.L. (Trieste, IT). The FDA issued a Cleared decision on July 16, 2010 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K092860

510(k) Number K092860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2009
Decision Date July 16, 2010
Days to Decision 302 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
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2892
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K092860.
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
K102050 · Advanced Technology Laser Co., Ltd. · Jul 2010
QUANTA DIODE LASER SYSTEM
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SUPRA SCAN DELIVERY SYSTEM
K100678 · Quantel Medical · Jul 2010
THERACLEAR
K101415 · Theravant Corporation · Jul 2010
CHEVEUX DIODE LASER SYSTEM
K100893 · Sandstone Medical Technologies, LLC · Jun 2010
FIBER ONE
K100746 · American Medical Systems · Jun 2010
K092860 · LASEMAR 800, 1000, 1500
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