Cleared Traditional

K861688 - XANAR CO2 SURGICAL LASER SYSTEM MODEL X...

K861688 is an FDA 510(k) clearance for XANAR CO2 SURGICAL LASER SYSTEM MODEL X..., manufactured by Xanar, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K861688 · Xanar, Inc. · General & Plastic Surgery device
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Oct 1986
Decision
154d
Days
Class 2
Risk

K861688 is an FDA 510(k) clearance for the XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15. 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 Xanar, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 154 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 Xanar, Inc. devices

FDA 510(k) Submission Details - K861688

510(k) Number K861688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1986
Decision Date October 03, 1986
Days to Decision 154 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
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 1459
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K861688.
MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
K862863 · Directed Energy, Inc. · Oct 1986
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY
K862864 · Directed Energy, Inc. · Oct 1986
ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY
K863183 · Cooper Lasersonics, Inc. · Oct 1986
MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)
K860831 · Cooper Lasersonics, Inc. · Oct 1986
MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
K862422 · Directed Energy, Inc. · Oct 1986
MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY
K862862 · Directed Energy, Inc. · Sep 1986