Cleared Traditional

K850805 - CO 2 SURGICAL LASER SYSTEM MODEL NA-40

K850805 is an FDA 510(k) clearance for CO 2 SURGICAL LASER SYSTEM MODEL NA-40, 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 169-day FDA review.

K850805 · Xanar, Inc. · General & Plastic Surgery device
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Aug 1985
Decision
169d
Days
Class 2
Risk

K850805 is an FDA 510(k) clearance for the CO 2 SURGICAL LASER SYSTEM MODEL NA-40. 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 August 15, 1985 after a review of 169 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 - K850805

510(k) Number K850805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1985
Decision Date August 15, 1985
Days to Decision 169 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
54d slower than avg
Panel avg: 115d · This submission: 169d
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 K850805.
MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE
K852860 · Coherent Medical Group · Oct 1985
MINI-HALO(HAND-HELD) CO2 LASER SYSTEM
K853319 · Directed Energy, Inc. · Sep 1985
MODEL 451 CO2 SURGICAL LASER
K852190 · Coherent Medical Group · Aug 1985
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY
K851000 · Cooper Lasersonics, Inc. · Aug 1985
870 SURGICAL SYS CONTROL PULSE MODIFICATION
K852252 · Cooper Lasersonics, Inc. · Jun 1985
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG
K850018 · Laserscope · Jun 1985