Cleared Traditional

K914089 - SHARPLAN SHARPLASE FAMILY OF HANDSWITCH...

K914089 is the FDA 510(k) clearance for SHARPLAN SHARPLASE FAMILY OF HANDSWITCH... 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 86-day FDA review.

K914089 · Sharplan Lasers, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
86d
Days
Class 2
Risk

K914089 is an FDA 510(k) clearance for the SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG. 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 December 6, 1991 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sharplan Lasers, Inc. devices

Submission Details

510(k) Number K914089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date December 06, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 K914089.
SIRIUS
K912813 · Pfizer Laser Systems · Dec 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K914952 · Trimedyne, Inc. · Dec 1991
C02 LASER WAVEGUIDE
K913887 · Heraeus Lasersonics, Inc. · Dec 1991
KTP/532 AND KTP/YAG
K913758 · Laserscope · Nov 1991
POLARIS, OPHTHALMOLOGY
K911926 · Pfizer Laser Systems · Nov 1991
CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY
K910530 · Heraeus Lasersonics, Inc. · Oct 1991