Cleared Traditional

K953794 - SHARPLAN LASERS

K953794 is the FDA 510(k) clearance for SHARPLAN LASERS 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 92-day FDA review.

K953794 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
92d
Days
Class 2
Risk

K953794 is an FDA 510(k) clearance for the SHARPLAN LASERS, INC. SURGICAL DIODE LASER. 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. (Warwick, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 92 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 Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K953794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1995
Decision Date November 14, 1995
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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 1420
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K953794.
6 WATT HOLMIUM LASER SYSTEM
K952489 · New Star Lasers, Inc. · Jan 1996
CERALAS G FREQUENCY DOUBLED ND
K954834 · Ceram Optec, Inc. · Jan 1996
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CANDELA MODEL PLTL-1 LASER SYSTEM
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LIHTAN 532 LASER
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SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940
K952661 · Surgical Laser Technologies, Inc. · Oct 1995