Cleared Traditional

K955862 - FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201

K955862 is an FDA 510(k) clearance for FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201, manufactured by Full Spectrum, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K955862 · Full Spectrum, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
65d
Days
Class 2
Risk

K955862 is an FDA 510(k) clearance for the FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201. 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 Full Spectrum, Inc. (Ames, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 65 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 Full Spectrum, Inc. devices

FDA 510(k) Submission Details - K955862

510(k) Number K955862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1995
Decision Date March 01, 1996
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
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 2194
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K955862.
PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES
K951876 · Xintec Corporation · Mar 1996
PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
K951935 · Xintec Corporation · Mar 1996
RIGHT ANGLE LASER FIBERS
K954597 · Trimedyne, Inc. · Mar 1996
SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER
K955621 · Sharplan Lasers, Inc. · Feb 1996
MEDLITE LASER SYSTEM
K955131 · Continuum Biomedical, Inc. · Feb 1996
CERALAS F ND:YAG LASER SYSTEM
K953851 · Ceram Optec, Inc. · Feb 1996