Cleared Traditional

K913918 - HERAEUS LASERSONICS TACTILASE STERILE D...

K913918 is the FDA 510(k) clearance for HERAEUS LASERSONICS TACTILASE STERILE D... 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 22-day FDA review.

K913918 · Heraeus Lasersonics, Inc. · General & Plastic Surgery device
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Sep 1991
Decision
22d
Days
Class 2
Risk

K913918 is an FDA 510(k) clearance for the HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER. 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 September 25, 1991 after a review of 22 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 K913918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date September 25, 1991
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 K913918.
DORNIER LASER LITHOTRIPTER IMPACT
K913191 · Dornier Medtech America, Inc. · Oct 1991
LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK
K913109 · Trimedyne, Inc. · Oct 1991
ENDOSTAT
K914104 · Laserscope · Sep 1991
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS)
K912793 · Surgical Laser Technologies, Inc. · Sep 1991
HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE
K913564 · Heraeus Lasersonics, Inc. · Sep 1991
LATERALASE STERILE DISPOSABLE FIBER
K913513 · Heraeus Lasersonics, Inc. · Sep 1991