Cleared Traditional

K902470 - COHERENT XA30/SP AND XA50 SURGICAL LASERS

K902470 is an FDA 510(k) clearance for COHERENT XA30/SP AND XA50 SURGICAL LASERS, 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 52-day FDA review.

K902470 · Lumenis, Inc. · General & Plastic Surgery device
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Jul 1990
Decision
52d
Days
Class 2
Risk

K902470 is an FDA 510(k) clearance for the COHERENT XA30/SP AND XA50 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. (Marlborough, US). The FDA issued a Cleared decision on July 26, 1990 after a review of 52 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 - K902470

510(k) Number K902470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1990
Decision Date July 26, 1990
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 K902470.
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA
K900890 · Nidek, Inc. · Sep 1990
NIDEK, INC. MODEL ADC-8000 DERM
K900925 · Nidek, Inc. · Sep 1990
LASER-SHIELD II(TM)
K901016 · Xomed, Inc. · Aug 1990
SLT CONTACT LASER SYSTEMS (UROLOGY)
K902241 · Surgical Laser Technologies, Inc. · Jul 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700
K902061 · Heraeus Lasersonics, Inc. · Jul 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700
K902148 · Heraeus Lasersonics, Inc. · Jul 1990