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TRIMEDYNE, INC.

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 1 of 3

Device	Model / Reference	Registries	Class	Status
Trimedyne® FlexMax® 365 Series Reusable Fiber (SMA Connector)	B365SMA	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Omni™ Multiuse Handpiece With Fiber Assembly (SMA Connector)	20471-HP	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Straightfire™ 25 cm Laser Needle	20302	FDA UDI	Class II	Active
Trimedyne® FlexMax® 1000 µm Single Use Holmium Fiber	S1000	FDA UDI	Class II	Active
Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber, 5m Length	B200-5M	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Side Firing 29 cm Laser Needle (SMA Connector)	20362-SMA	FDA UDI	Class II	Active
Trimedyne® FlexMax® 200 µm Single Use Holmium Fiber (SMA Connector)	S200SMA	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - 30° (SMA Connector)	20402-SMA	FDA UDI	Class II	Active
Trimedyne® VaporMAX® - Ho:YAG Side Firing Fiber-Optic Instrument	20444	FDA UDI	Class II	Active
Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System	1210-VHP	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - 30°	20402-M	FDA UDI	Class II	Active
Trimedyne® FlexMax® 272 µm Reusable Fiber (SMA Connector)	B272SMA	FDA UDI	Class II	Active
Trimedyne® 1210-VHPA OmniPulse Max™ Holmium Laser System	1210-VHPA	FDA UDI	Class II	Active
Trimedyne® FlexMax® 1000 µm Single Use Fiber (SMA Connector)	S1000SMA	FDA UDI	Class II	Active
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece	20442	FDA UDI	Class II	Active
Trimedyne® OmniTip™ Switchable Tip - 60°	20478-HP	FDA UDI	Class II	Active
Trimedyne® R-50™ Spinal Introduction Cannula	70052	FDA UDI	Class II	Active
Trimedyne® OmniTip™ Switchable Tip - 20°	20475-HP	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - 20°	20405-M	FDA UDI	Class II	Active
Trimedyne® FlexMax® 272 µm Single Use Holmium Bare Fiber	S272	FDA UDI	Class II	Active
Trimedyne® Reposable OmniTip™ Switchable Tip - 30°	20476M-HP	FDA UDI	Class II	Active
Trimedyne® FlexMax® 272 µm Single Use Holmium Fiber (SMA Connector)	S272SMA	FDA UDI	Class II	Active
100 Watt Holmium Side Fire Fiber	SF-600	FDA UDI	Class II	Active
Trimedyne® FlexMax® 10000 µm Reusable Holmium Bare Fiber (SMA Connector)	20025M-SMA	FDA UDI	Class II	Active
Trimedyne® VaporMax® - Ho:YAG Side Firing Fiber-Optic Instrument	20444-SMA	FDA UDI	Class II	Active
Trimedyne® OmniTip™ Switchable Tip - Straight	20474-HP	FDA UDI	Class II	Active
Trimedyne® 1230-30 OmniPulse Jr.™ Holmium Laser System	1230-30	FDA UDI	Class II	Active
Trimedyne® Gas-Cooled 600 µm Fiber with Nozzle Tip (SMA Connector)	20503	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - Straight	20401-M	FDA UDI	Class II	Active
Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber	20021-M	FDA UDI	Class II	Active
Trimedyne® FlexMax® 365 Series Reusable Holmium Bare Fiber	B365	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Omni™ Multiuse Handpiece With Fiber Assembly	20470-HP	FDA UDI	Class II	Active
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece	20440-SMA	FDA UDI	Class II	Active
Trimedyne® OmniTip™ Switchable Tip - Side Firing	20479-HP	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - 60°	20403-M	FDA UDI	Class II	Active
Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight	20497-HP	FDA UDI	Class II	Active
Trimedyne® FlexMax® 1000 µm Reusable Holmium Bare Fiber	20025-M	FDA UDI	Class II	Active
Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber (SMA Connector)	20021M-SMA	FDA UDI	Class II	Active
Trimedyne® FlexMax® 365 µm Single Use Holmium Bare Fiber	S365	FDA UDI	Class II	Active
Trimedyne® Omni™ Sterilization Tray System	7205	FDA UDI	Class I	Active
Trimedyne® OmniTip™ Switchable Tip - 30°	20476-HP	FDA UDI	Class II	Active
Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece	20442-SMA	FDA UDI	Class II	Active
Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable Tip	20489-HP	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - 20° (SMA Connector)	20405-SMA	FDA UDI	Class II	Active
Trimedyne® 1210 OmniPulse™ Holmium Laser System	1210	FDA UDI	Class II	Active
Trimedyne® Model 1500-A Holmium Laser System	1500-A	FDA UDI	Class II	Active
Trimedyne® FlexMax® 200 µm Reusable Fiber (SMA Connector)	B200SMA	FDA UDI	Class II	Active
Trimedyne® FlexMax® 200 µm Reusable Fiber (SMA Connector), 5m Length	B2005M-SMA	FDA UDI	Class II	Active
Trimedyne® Reposable OmniTip™ Switchable Tip - 20°	20475M-HP	FDA UDI	Class II	Active
Trimedyne® Ho:YAG Tapertip™ - Side Firing (SMA Connector)	20409-SMA	FDA UDI	Class II	Active

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