Cleared Traditional

K923855 - SHARPULSE

K923855 is the FDA 510(k) clearance for SHARPULSE by Sharplan Lasers, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K923855 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Dec 1992
Decision
167d
Days
Class 2
Risk

K923855 is an FDA 510(k) clearance for the SHARPULSE. 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 Lasers, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on December 24, 1992 after a review of 167 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 Lasers, Inc. devices

Submission Details

510(k) Number K923855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date December 24, 1992
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
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 1419
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K923855.
DORNIER FIBERTOME 100 WATT SURGICAL LASER
K921549 · Dornier Medtech America, Inc. · Feb 1993
CANDELA LASSER SYSTEMS MODIFIED
K924158 · Candela Laser Corp. · Jan 1993
EXCEL TRIPULSE MODEL3000
K924729 · Excel Tech. , Ltd. · Jan 1993
HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS
K923896 · Heraeus Lasersonics, Inc. · Nov 1992
INCISOR I PULSED ND:YAG LASER SYSTEM
K922901 · Buckman Co., Inc. · Nov 1992
MEGABEAM
K923953 · Ceram Optec, Inc. · Nov 1992