Cleared Traditional

K895143 - COHERENT XA-50

K895143 is an FDA 510(k) clearance for COHERENT XA-50, manufactured by Lumenis, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K895143 · Lumenis, Inc. · General & Plastic Surgery device
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Sep 1989
Decision
38d
Days
Class 2
Risk

K895143 is an FDA 510(k) clearance for the COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS. 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 Lumenis, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 25, 1989 after a review of 38 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 Lumenis, Inc. devices

FDA 510(k) Submission Details - K895143

510(k) Number K895143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date September 25, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
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 1544
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K895143.
SHARPLAN MODEL 710 MICROSPOT
K895746 · Sharplan Lasers, Inc. · Oct 1989
NIDEK MODEL ADC-8000
K894709 · Nidek, Inc. · Oct 1989
SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY
K895042 · Sharplan Lasers, Inc. · Sep 1989
SLT CONTACT LASER SYSTEMS
K895093 · Surgical Laser Technologies, Inc. · Sep 1989
SURGIFLEX LASER CONTACT TIPS
K894186 · Cabot Medical Corp. · Sep 1989
MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND
K894164 · Heraeus Lasersonics, Inc. · Aug 1989