Cleared Traditional

K941312 - SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN

K941312 is the FDA 510(k) clearance for SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN 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 104-day FDA review.

K941312 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
104d
Days
Class 2
Risk

K941312 is an FDA 510(k) clearance for the SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN. 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. (Allendale, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 104 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 K941312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date June 30, 1994
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
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 K941312.
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
K942152 · Candela Laser Corp. · Jul 1994
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B
K933318 · Lumenis, Inc. · Jul 1994
MEGABEAM DENTAL FIBER
K942182 · Ceram Optec, Inc. · Jul 1994
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM
K932883 · Trimedyne, Inc. · Jun 1994
DISPOSABLE SPINAL INTRODUCER SHEATH
K941419 · Trimedyne, Inc. · Jun 1994
SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES
K935563 · Sharplan Lasers, Inc. · May 1994