Cleared Traditional

K895430 - HERAEUS LASERSONICS ND:YAG LASER

K895430 is the FDA 510(k) clearance for HERAEUS LASERSONICS ND:YAG LASER 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 84-day FDA review.

K895430 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
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Nov 1989
Decision
84d
Days
Class 2
Risk

K895430 is an FDA 510(k) clearance for the HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100. 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 November 28, 1989 after a review of 84 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 K895430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date November 28, 1989
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 K895430.
OPTILASE YAG MODEL 1000
K895874 · Trimedyne, Inc. · Jan 1990
STERILE DISPOSABLE INFRATIP
K895918 · Heraeus Lasersonics, Inc. · Dec 1989
COHERENT HOLMIUM:YAG SURGICAL LASER
K895518 · Lumenis, Inc. · Nov 1989
ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
K895263 · Heraeus Lasersonics, Inc. · Oct 1989
SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION
K895029 · Surgical Laser Technologies, Inc. · Oct 1989
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K894977 · Trimedyne, Inc. · Oct 1989