Cleared Traditional

K991464 - DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50

K991464 is an FDA 510(k) clearance for DENTAL 200, manufactured by Fisma, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K991464 · Fisma, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
84d
Days
Class 2
Risk

K991464 is an FDA 510(k) clearance for the DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50. 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 Fisma, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 20, 1999 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 Fisma, Inc. devices

FDA 510(k) Submission Details - K991464

510(k) Number K991464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1999
Decision Date July 20, 1999
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
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.

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 1881
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K991464.
DENTEC LD 15 DIODE LASER
K990680 · Dentek Lasersystems Produktions Ges.M.B.H. · Jul 1999
POLARIS DIODE LASER SYSTEM AND ACCESSORIES
K990914 · Xintec Corporation · Jul 1999
UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
K991659 · Medart Corp. · Jul 1999
LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
K991285 · Aesculap-Meditec North America · Jul 1999
UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES
K991297 · Medart Corp. · Jul 1999
CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
K992084 · Cynosure, Inc. · Jul 1999