Cleared Traditional

K955861 - MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER

K955861 is an FDA 510(k) clearance for MICROQUARTZ MEDICAL TYPE B SIDE-FIRING ..., manufactured by Microquartz Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K955861 · Microquartz Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
30d
Days
Class 2
Risk

K955861 is an FDA 510(k) clearance for the MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER. 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 Microquartz Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 30 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 Microquartz Medical, Inc. devices

FDA 510(k) Submission Details - K955861

510(k) Number K955861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1995
Decision Date January 26, 1996
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
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 2026
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K955861.
ACCUSCAN MODEL C CO2 LASER SCANNER
K953670 · Reliant Technologies, Inc. · Jan 1996
APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM
K955007 · Applied Optronics Corp. · Jan 1996
APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE
K955014 · Applied Optronics Corp. · Jan 1996
INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS
K954195 · Indigo Medical, Inc. · Jan 1996
OMEGA ULTRASCAN
K954911 · Gyne-Tech Instrument Corp. · Jan 1996
6 WATT HOLMIUM LASER SYSTEM
K952489 · New Star Lasers, Inc. · Jan 1996