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TRIMEDYNE, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
519 N. Smith Avenue, Suite 105, Corona, CA, 92878
Website
trimedyne.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
8007335273
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
1419951
DUNS Number
057007239

Catalogue (123)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
Trimedyne® 550 µm Test Laser Fiberoptic 760
FDA UDI
Class IIActive
Trimedyne® FlexMax® 272 µm Reusable Holmium Bare Fiber B272
FDA UDI
Class IIActive
Trimedyne® FlexMax® 365 µm Single Use Holmium Fiber (SMA Connector) S365SMA
FDA UDI
Class IIActive
Trimedyne® OmniTip™ - 30 cm Side Firing Switchable Tip with Suction/Irrigation 20371-HP
FDA UDI
Class IIActive
Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight 20495-HP
FDA UDI
Class IIActive
Trimedyne® FlexMax® 550 µm Single Use Fiber (SMA Connector) S550SMA
FDA UDI
Class IIActive
Trimedyne® FlexMax® 550 µm Single Use Holmium Fiber S550
FDA UDI
Class IIActive
Trimedyne® OmniTip™ - 35 cm Side Firing Switchable Tip with Irrigation 20373-HP
FDA UDI
Class IIActive
Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Side Firing 20496-HP
FDA UDI
Class IIActive
Trimedyne® FlexMax® 200 µm Single Use Holmium Bare Fiber S200
FDA UDI
Class IIActive
Trimedyne® OmniTip™ 25 cm Side Firing Laser Needle 20462-HP
FDA UDI
Class IIActive
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece 20440
FDA UDI
Class IIActive
Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber B200
FDA UDI
Class IIActive
Trimedyne® 2120 OmniPulse Mini™ Holmium Laser System 2120
FDA UDI
Class IIActive
Omnitip Side Firing Switchable Tip With Suction/Irrigation, Model 20371-Hp K992230
FDA 510(k)
Class IIActive
Enteroscope K840722
FDA 510(k)
Class IIActive
Trimedyne Model 1210 Omnipulse Holmium Laser Syst K911457
FDA 510(k)
Class IIActive
Omnipulse/Omnipulse-Max K962632
FDA 510(k)
Class IIActive
Model 1210 Omnipulse Holmium Laser System K915117
FDA 510(k)
Class IIActive
Halocath Laser Catheters K920934
FDA 510(k)
Class IIActive
Optilase Model 1000-100 Nd: Yag Laser System K932883
FDA 510(k)
Class IIActive
Lateralase, Modified K944204
FDA 510(k)
Class IIActive
Lateralase(tm) Catheter With Thermal Feedback K913109
FDA 510(k)
Class IIActive
Gyn-Probe K895774
FDA 510(k)
Class IIActive
Trimedyne Holmium Laser Systems K041660
FDA 510(k)
Class IIActive
Rmnipulse Holmium Laser System/1210; Max/1210-Vhp; Jr. 1230-30; N/A 1500-A K013974
FDA 510(k)
Class IIActive
Optilase Yag Model 1000 Surgical Laser System K894977
FDA 510(k)
Class IIActive
Optilase Yag Model 1000 Surg Laser System/Gastro K861173
FDA 510(k)
Class IIActive
Right Angle Laser Fibers K954597
FDA 510(k)
Class IIActive
Endoscopic Electrosurgical Fiberoptic Probe K861331
FDA 510(k)
Class IIActive
Model 1210 Omnipulse Holmium Laser System K914952
FDA 510(k)
Class IIActive
Omnipulse Mini, Model 2120 K043012
FDA 510(k)
Class IIActive
Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210, 1210-Vhp, 1500-A K001676
FDA 510(k)
Class IIActive
Lateralase K920625
FDA 510(k)
Class IIActive
Optilase Yag Model 1000 Acv Surgical Laser System K897157
FDA 510(k)
Class IIActive
Hotip Hemostatic Probe K843628
FDA 510(k)
Class IIActive
Lateralase Tm K903418
FDA 510(k)
Class IIActive
Right Angle Laser Fibers;optilase Nd:yag Laser;optilase Pl100 Nd Laser Systems K970422
FDA 510(k)
Class IIActive
Vapormax Ii K053457
FDA 510(k)
Class IIActive
Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models 1210-Vhp, 1500a K992574
FDA 510(k)
Class IIActive
Optilase Yag Model 1000 K895874
FDA 510(k)
Class IIActive
Trimedyne Side Firing Needle With Vent Sheath K022655
FDA 510(k)
Class IIActive
Lateralase Catheter K925414
FDA 510(k)
Class IIActive
Metal Enclosed Side Firing Fibers K915223
FDA 510(k)
Class IIActive
Disposable Spinal Introducer Sheath K941419
FDA 510(k)
Class IIActive
Side Firing Fibers K920632
FDA 510(k)
Class IIActive
Laser-Assisted Disk Decompression Accessory Pack K922213
FDA 510(k)
Class IIActive
Angioscope W/The Optiscope-2 Integrated Angioscopy K895538
FDA 510(k)
Class IIActive
Resposable Bare Fibers K973172
FDA 510(k)
Class IIActive
Omnipulse-Max Holmium Laser K951562
FDA 510(k)
Class IIActive

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