Cleared Traditional

K861044 - MODEL 2100 ND:YAG SURGICAL LASER NEUROS...

K861044 is the FDA 510(k) clearance for MODEL 2100 ND:YAG SURGICAL LASER NEUROS... by Sharplan Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K861044 · Sharplan Industries, Inc. · General & Plastic Surgery device
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Oct 1986
Decision
224d
Days
Class 2
Risk

K861044 is an FDA 510(k) clearance for the MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND. 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 Sharplan Industries, Inc. (Washington, US). The FDA issued a Cleared decision on October 28, 1986 after a review of 224 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 Sharplan Industries, Inc. devices

Submission Details

510(k) Number K861044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date October 28, 1986
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 737
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K861044.
SHARPLAN 719Y MICROSLAD(TM)
K881887 · Sharplan Lasers, Inc. · May 1988
MODIFIED MODEL 2100 ND:YAG LASER
K881848 · Sharplan Lasers, Inc. · May 1988
CODMAN NEUROLASE LASER SYSTEM
K872179 · Codman & Shurtleff, Inc. · Oct 1987
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
K860087 · Sharplan Lasers, Inc. · Apr 1986
CODMAN LASER BACKSTOP
K853626 · Codman & Shurtleff, Inc. · Feb 1986
CODMAN LASER RODS
K853627 · Codman & Shurtleff, Inc. · Feb 1986