Cleared Traditional

K914396 - SURGI LIGHT NON-CONTACT FIBERS

K914396 is an FDA 510(k) clearance for SURGI LIGHT NON-CONTACT FIBERS, manufactured by Lifestream Int'L, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K914396 · Lifestream Int'L, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
83d
Days
Class 2
Risk

K914396 is an FDA 510(k) clearance for the SURGI LIGHT NON-CONTACT FIBERS. 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 Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on December 23, 1991 after a review of 83 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 Lifestream Int'L, Inc. devices

FDA 510(k) Submission Details - K914396

510(k) Number K914396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date December 23, 1991
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
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 1537
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914396.
LATERALASE
K915354 · Trimedyne, Inc. · Feb 1992
METAL ENCLOSED SIDE FIRING FIBERS
K915223 · Trimedyne, Inc. · Jan 1992
SIRIUS
K912813 · Pfizer Laser Systems · Dec 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K914952 · Trimedyne, Inc. · Dec 1991
C02 LASER WAVEGUIDE
K913887 · Heraeus Lasersonics, Inc. · Dec 1991
SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG
K914089 · Sharplan Lasers, Inc. · Dec 1991