Cleared Traditional

K963996 - (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400

K963996 is an FDA 510(k) clearance for (FSI) LAPAROSCOPIC PROBE FOR ALL FSI UL..., 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 202-day FDA review.

K963996 · Full Spectrum, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
202d
Days
Class 2
Risk

K963996 is an FDA 510(k) clearance for the (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX.... 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 April 24, 1997 after a review of 202 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Full Spectrum, Inc. devices

FDA 510(k) Submission Details - K963996

510(k) Number K963996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1996
Decision Date April 24, 1997
Days to Decision 202 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
87d slower than avg
Panel avg: 115d · This submission: 202d
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 2195
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K963996.
CENTAURI
K932683 · Premier Laser Systems, Inc. · May 1997
CENTAURI
K933841 · Premier Laser Systems, Inc. · May 1997
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
K963991 · Full Spectrum, Inc. · Apr 1997
RIGHT ANGLE LASER FIBERS
K970422 · Trimedyne, Inc. · Apr 1997
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
K964585 · Trimedyne, Inc. · Apr 1997
VENISECT LASER LANCET
K955653 · Venisect, Inc. · Apr 1997