Cleared Traditional

K971912 - PROTEGE ER:YAG LASER SYSTEM AND ACCESSO...

K971912 is the FDA 510(k) clearance for PROTEGE ER:YAG LASER SYSTEM AND ACCESSO... by Xintec Corporation. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K971912 · Xintec Corporation · General & Plastic Surgery device
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Nov 1997
Decision
206d
Days
Class 2
Risk

K971912 is an FDA 510(k) clearance for the PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES. 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 (Oakland, US). The FDA issued a Cleared decision on November 3, 1997 after a review of 206 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 Xintec Corporation devices

Submission Details

510(k) Number K971912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1997
Decision Date November 03, 1997
Days to Decision 206 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 115d · This submission: 206d
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 1064
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K971912.
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
K972767 · Candela Corp. · Dec 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
K973354 · Sharplan Lasers, Inc. · Dec 1997
CYNOSURE PHOTOGENICA ER LASER
K973498 · Cynosure, Inc. · Nov 1997
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
K972347 · Lumenis, Inc. · Sep 1997
CYNOSURE DERMATOLOGY LASER COOLING TIP
K972002 · Cynosure, Inc. · Aug 1997
SHARPLAN EPITOUCH RUBY LASER SYSTEM
K972099 · Sharplan Lasers, Inc. · Aug 1997