Cleared Traditional

K914952 - MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM

K914952 is an FDA 510(k) clearance for MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM, manufactured by Trimedyne, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K914952 · Trimedyne, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
45d
Days
Class 2
Risk

K914952 is an FDA 510(k) clearance for the MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM. 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 Trimedyne, Inc. (Irvine, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 45 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 Trimedyne, Inc. devices

FDA 510(k) Submission Details - K914952

510(k) Number K914952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1991
Decision Date December 20, 1991
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 1565
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914952.
METAL ENCLOSED SIDE FIRING FIBERS
K915223 · Trimedyne, Inc. · Jan 1992
SIRIUS
K912813 · Pfizer Laser Systems · Dec 1991
SURGI LIGHT NON-CONTACT FIBERS
K914396 · Lifestream Int'L, Inc. · Dec 1991
C02 LASER WAVEGUIDE
K913887 · Heraeus Lasersonics, Inc. · Dec 1991
SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG
K914089 · Sharplan Lasers, Inc. · Dec 1991
KTP/532 AND KTP/YAG
K913758 · Laserscope · Nov 1991