Cleared Traditional

K801624 - SHARPLAN 723 CO2 LASER SURGICAL SYSTEM

K801624 is an FDA 510(k) clearance for SHARPLAN 723 CO2 LASER SURGICAL SYSTEM, manufactured by Laser Industries , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K801624 · Laser Industries , Ltd. · General & Plastic Surgery device
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Aug 1980
Decision
36d
Days
Class 2
Risk

K801624 is an FDA 510(k) clearance for the SHARPLAN 723 CO2 LASER SURGICAL SYSTEM. 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 Laser Industries , Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 36 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 Laser Industries , Ltd. devices

FDA 510(k) Submission Details - K801624

510(k) Number K801624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date August 20, 1980
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 2420
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K801624.
SHARPLAN #734 LASER SURGICAL UNIT
K832550 · Laser Industries , Ltd. · Apr 1984
MODEL 450XL CO2 SURGICAL LASER
K820327 · Lumenis, Inc. · Mar 1982
SHARPLAN 720 CO2 SURGICAL LASER
K820101 · Laser Industries , Ltd. · Feb 1982
SHARPLAN 743, CO2 LASER SURGICAL SYSTEM
K792418 · Laser Industries , Ltd. · Feb 1980
LASER SYSTEM, SHARPLAN 791/HE, CO2
K782030 · Laser Industries , Ltd. · Jan 1979
SURGICAL LASER
K780585 · Laser Industries , Ltd. · Jul 1978