Cleared Traditional

K902061 - MODELS 4000

K902061 is the FDA 510(k) clearance for MODELS 4000 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 64-day FDA review.

K902061 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
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Jul 1990
Decision
64d
Days
Class 2
Risk

K902061 is an FDA 510(k) clearance for the MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&1700. 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 July 10, 1990 after a review of 64 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 K902061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date July 10, 1990
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 K902061.
LASER-SHIELD II(TM)
K901016 · Xomed, Inc. · Aug 1990
COHERENT XA30/SP AND XA50 SURGICAL LASERS
K902470 · Lumenis, Inc. · Jul 1990
SLT CONTACT LASER SYSTEMS (UROLOGY)
K902241 · Surgical Laser Technologies, Inc. · Jul 1990
MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,1700
K902148 · Heraeus Lasersonics, Inc. · Jul 1990
ADD'L USE OF THE KTP/YAG SURGICAL LASER
K902058 · Laserscope · Jun 1990
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
K901481 · Nidek, Inc. · Jun 1990