Cleared Traditional

K903444 - MDLS 4000/4900/6000/8000/8900/LUXUS 60/...

K903444 is the FDA 510(k) clearance for MDLS 4000/4900/6000/8000/8900/LUXUS 60/... by Heraeus Lasersonics, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K903444 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 1990
Decision
76d
Days
Class 2
Risk

K903444 is an FDA 510(k) clearance for the MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 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 Heraeus Lasersonics, Inc. (Milpitas, US). The FDA issued a Cleared decision on October 11, 1990 after a review of 76 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 Heraeus Lasersonics, Inc. devices

Submission Details

510(k) Number K903444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1990
Decision Date October 11, 1990
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 1170
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K903444.
MEDILAS 4060N FIBERTOM(R) SURGICAL LASER
K904155 · Dornier Medtech America, Inc. · Nov 1990
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K903936 · Surgical Laser Technologies, Inc. · Oct 1990
SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 1075
K903230 · Sharplan Lasers, Inc. · Oct 1990
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
K900858 · Candela Laser Corp. · Oct 1990
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K902939 · Trimedyne, Inc. · Oct 1990
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
K902940 · Trimedyne, Inc. · Oct 1990