Cleared Traditional

K854833 - MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI

K854833 is an FDA 510(k) clearance for MDS-83 IN DERMATOLOGICAL/PLASTIC SURGER..., manufactured by Meditec, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K854833 · Meditec, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 1986
Decision
126d
Days
Class 2
Risk

K854833 is an FDA 510(k) clearance for the MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI. 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 Meditec, Inc. (Clearwater, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 126 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 Meditec, Inc. devices

FDA 510(k) Submission Details - K854833

510(k) Number K854833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1985
Decision Date April 04, 1986
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
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 2372
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K854833.
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM
K860087 · Sharplan Lasers, Inc. · Apr 1986
MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY
K860273 · Britt Corp., Inc. · Apr 1986
MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC
K860278 · Britt Corp., Inc. · Apr 1986
MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM
K854386 · Directed Energy, Inc. · Mar 1986
AURORA M MEDICAL DYE LASER
K855246 · Cooper Lasersonics, Inc. · Mar 1986
ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY
K853877 · Endo Lase, Inc. · Feb 1986