Cleared Traditional

K951760 - OPTILITE VIII LASER SURGERY ACCESSORIES

K951760 is the FDA 510(k) clearance for OPTILITE VIII LASER SURGERY ACCESSORIES by Xintec Corporation. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K951760 · Xintec Corporation · General & Plastic Surgery device
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Nov 1995
Decision
226d
Days
Class 2
Risk

K951760 is an FDA 510(k) clearance for the OPTILITE VIII LASER SURGERY 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 29, 1995 after a review of 226 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 K951760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date November 29, 1995
Days to Decision 226 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
111d slower than avg
Panel avg: 115d · This submission: 226d
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 K951760.
SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER
K955621 · Sharplan Lasers, Inc. · Feb 1996
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION)
K954727 · Surgical Laser Technologies, Inc. · Feb 1996
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
K954934 · Candela Laser Corp. · Feb 1996
SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM
K952277 · Sharplan Lasers, Inc. · Nov 1995
SHARPLAN LASERS, INC. SURGICAL DIODE LASER
K953794 · Sharplan Lasers, Inc. · Nov 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
K953412 · Candela Laser Corp. · Oct 1995