Cleared Traditional

K862815 - LASER SURGICAL ROD

K862815 is an FDA 510(k) clearance for LASER SURGICAL ROD, 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 116-day FDA review.

K862815 · Lifestream Int'L, Inc. · General & Plastic Surgery device
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Nov 1986
Decision
116d
Days
Class 2
Risk

K862815 is an FDA 510(k) clearance for the LASER SURGICAL ROD. 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. (Houston, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 116 days - within the typical 510(k) review window.

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 Lifestream Int'L, Inc. devices

FDA 510(k) Submission Details - K862815

510(k) Number K862815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1986
Decision Date November 17, 1986
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
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 K862815.
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO
K862514 · Laserscope · Feb 1987
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG
K863086 · Cooper Lasersonics, Inc. · Dec 1986
CANDELA MODEL SPT-1, PULSED DYE LASER
K861179 · Candela Corp. · Nov 1986
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
K862408 · Directed Energy, Inc. · Oct 1986
MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
K862863 · Directed Energy, Inc. · Oct 1986
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY
K862864 · Directed Energy, Inc. · Oct 1986