Cleared Traditional

K923896 - HERCULES MODEL 5060 AND 5100 ND:YAG LAS...

K923896 is the FDA 510(k) clearance for HERCULES MODEL 5060 AND 5100 ND:YAG LAS... 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 113-day FDA review.

K923896 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
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Nov 1992
Decision
113d
Days
Class 2
Risk

K923896 is an FDA 510(k) clearance for the HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS. 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 25, 1992 after a review of 113 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 Heraeus Lasersonics, Inc. devices

Submission Details

510(k) Number K923896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date November 25, 1992
Days to Decision 113 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
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 K923896.
CANDELA LASSER SYSTEMS MODIFIED
K924158 · Candela Laser Corp. · Jan 1993
EXCEL TRIPULSE MODEL3000
K924729 · Excel Tech. , Ltd. · Jan 1993
SHARPULSE
K923855 · Sharplan Lasers, Inc. · Dec 1992
INCISOR I PULSED ND:YAG LASER SYSTEM
K922901 · Buckman Co., Inc. · Nov 1992
ALCON(R) FX2(TM) PHOTOCOAGULATOR
K914334 · Alcon Laboratories · Nov 1992
ZEISS VISULAS ARGON LASER
K923341 · Carl Zeiss, Inc. · Oct 1992