TRIMEDYNE, INC.

Address:519 N. Smith Avenue, Suite 105,Corona,CA,92878,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

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Trimedyne® 1210 OmniPulse™ Holmium Laser System - M47312100 Catalog Number : 1210

Device Description : Model 1210 - OmniPulse Holmium Laser System

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® 1210-VHP OmniPulse Max™ Holmium Laser System - M4731210VHP0 Catalog Number : 1210-VHP

Device Description : Model 1210-VHP - OmniPulse Max Holmium Laser System

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® 1210-VHPA OmniPulse Max™ Holmium Laser System - M4731210VHPA0 Catalog Number : 1210-VHPA

Device Description : Model 1210-VHPA - OmniPulse Max Holmium Laser System

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® 1230-30 OmniPulse Jr.™ Holmium Laser System - M4731230300 Catalog Number : 1230-30

Device Description : Model 1230-30 - OmniPulse Jr. Holmium Laser System

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® Model 1500-A Holmium Laser System - M4731500A0 Catalog Number : 1500-A

Device Description : Model 1500-A - Holmium Laser System

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber - M47320021M0 Catalog Number : 20021-M

Device Description : Fiber, Bare, 550um, Reusable, TMED Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber (SMA Connector) - M47320021MSMA0 Catalog Number : 20021M-SMA

Device Description : Fiber, Bare, 550um, Reusable, SMA Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 1000 µm Reusable Holmium Bare Fiber - M47320025M0 Catalog Number : 20025-M

Device Description : Fiber, Bare, 1000um, Reusable, TMED Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 10000 µm Reusable Holmium Bare Fiber (SMA Connector) - M47320025MSMA0 Catalog Number : 20025M-SMA

Device Description : Fiber, Bare, 1000um, Reusable, SMA Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® Ho:YAG Straightfire™ 25 cm Laser Needle - M473203020 Catalog Number : 20302

Device Description : Diskectomy, Straightfire, Long

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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