Cleared Traditional

K913290 - MULTILASE 2100 A

K913290 is an FDA 510(k) clearance for MULTILASE 2100 A, manufactured by Teknomed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K913290 · Teknomed, Inc. · General & Plastic Surgery device
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Feb 1992
Decision
212d
Days
Class 2
Risk

K913290 is an FDA 510(k) clearance for the MULTILASE 2100 A. 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 Teknomed, Inc. (Danvers, US). The FDA issued a Cleared decision on February 21, 1992 after a review of 212 days - an extended review 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: 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 Teknomed, Inc. devices

FDA 510(k) Submission Details - K913290

510(k) Number K913290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1991
Decision Date February 21, 1992
Days to Decision 212 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 115d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

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 1459
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K913290.
LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY
K912618 · Heraeus Lasersonics, Inc. · Feb 1992
EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM
K914849 · Excel Tech. , Ltd. · Feb 1992
LATERALASE
K915354 · Trimedyne, Inc. · Feb 1992
METAL ENCLOSED SIDE FIRING FIBERS
K915223 · Trimedyne, Inc. · Jan 1992
SIRIUS
K912813 · Pfizer Laser Systems · Dec 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K914952 · Trimedyne, Inc. · Dec 1991