Cleared Traditional

K853319 - MINI-HALO(HAND-HELD) CO2 LASER SYSTEM

K853319 is an FDA 510(k) clearance for MINI-HALO(HAND-HELD) CO2 LASER SYSTEM, manufactured by Directed Energy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K853319 · Directed Energy, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
43d
Days
Class 2
Risk

K853319 is an FDA 510(k) clearance for the MINI-HALO(HAND-HELD) CO2 LASER 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 Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 43 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 Directed Energy, Inc. devices

FDA 510(k) Submission Details - K853319

510(k) Number K853319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1985
Decision Date September 19, 1985
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
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 1536
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K853319.
ENDO-LASE CD40 FOR UROLOGY
K853904 · Endo Lase, Inc. · Oct 1985
TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700
K851405 · Trimedyne, Inc. · Oct 1985
MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE
K852860 · Coherent Medical Group · Oct 1985
MODEL 451 CO2 SURGICAL LASER
K852190 · Coherent Medical Group · Aug 1985
COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY
K851000 · Cooper Lasersonics, Inc. · Aug 1985
870 SURGICAL SYS CONTROL PULSE MODIFICATION
K852252 · Cooper Lasersonics, Inc. · Jun 1985