Cleared Traditional

K892933 - INFRALASE-LASERGUIDE DELIVERY SYSTEM

K892933 is an FDA 510(k) clearance for INFRALASE-LASERGUIDE DELIVERY SYSTEM, manufactured by Ximed Medical Systems. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K892933 · Ximed Medical Systems · General & Plastic Surgery device
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Jun 1989
Decision
62d
Days
Class 2
Risk

K892933 is an FDA 510(k) clearance for the INFRALASE-LASERGUIDE DELIVERY SYSTEM. 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 Ximed Medical Systems (Santa Clara, US). The FDA issued a Cleared decision on June 22, 1989 after a review of 62 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 Ximed Medical Systems devices

FDA 510(k) Submission Details - K892933

510(k) Number K892933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date June 22, 1989
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 2077
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K892933.
SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER
K894396 · Surgilase, Inc. · Aug 1989
OPMILAS CO2-L
K894393 · Carl Zeiss, Inc. · Jul 1989
MODIFIED ENDOGUIDE
K893642 · Luxar Corp. · Jul 1989
SHARPLAN 1075 CO2 LASER
K893206 · Sharplan Lasers, Inc. · Jun 1989
SLT CONTACT LASER SYSTEM
K893701 · Surgical Laser Technologies, Inc. · Jun 1989
CANDELA PLDL-1 PULSED DYE LASER
K892516 · Candela Laser Corp. · Jun 1989