Cleared Traditional

K011960 - LARES RESEARCH SUNLASE 800P LASER SYSTE...

K011960 is the FDA 510(k) clearance for LARES RESEARCH SUNLASE 800P LASER SYSTE... by Lares Research, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K011960 · Lares Research, Inc. · General & Plastic Surgery device
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Dec 2001
Decision
182d
Days
Class 2
Risk

K011960 is an FDA 510(k) clearance for the LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPR.... 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 Lares Research, Inc. (Chico, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 182 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 Lares Research, Inc. devices

Submission Details

510(k) Number K011960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2001
Decision Date December 21, 2001
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
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 741
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K011960.
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
K023182 · Ethicon Endo-Surgery, Inc. · Oct 2002
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
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SMARTEPIL
K020107 · Cynosure, Inc. · Feb 2002
INDIGO OPTIMA LASER SYSTEM
K013493 · Ethicon Endo-Surgery, Inc. · Dec 2001
CYNOSURE PHOTOGENICA VL
K012806 · Cynosure, Inc. · Nov 2001
CYNOSURE PHOTOGENICA ER
K012790 · Cynosure, Inc. · Nov 2001