Cleared Traditional

K060114 - VECTRA LASER SYSTEM

K060114 is an FDA 510(k) clearance for VECTRA LASER SYSTEM, manufactured by Xintec Corporation, Dba,. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K060114 · Xintec Corporation, Dba, · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
80d
Days
Class 2
Risk

K060114 is an FDA 510(k) clearance for the VECTRA LASER SYSTEM. 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 Xintec Corporation, Dba, (Alameda, US). The FDA issued a Cleared decision on April 7, 2006 after a review of 80 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 Xintec Corporation, Dba, devices

FDA 510(k) Submission Details - K060114

510(k) Number K060114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date April 07, 2006
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 1989
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K060114.
ACMI DUR-HL LASER SYSTEMS
K060752 · Acmi Corporation · May 2006
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
K051442 · Cynosure, Inc. · May 2006
LIGHTSHEER DUET LASER SYSTEM
K053628 · Lumenis, Inc. · Apr 2006
LASERTX - DIODE LASER & DELIVERY SYSTEM
K060326 · Prosurg, Inc. · Apr 2006
FRAXEL II SR LASER SYSTEM AND ACCESSORIES
K060310 · Reliant Technologies, Inc. · Mar 2006
PALOMAR LUX1540 HANDPIECE
K060301 · Palomar Medical Technologies, Inc. · Mar 2006