Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419951

FEI Number

1419951

Entity Name

TRIMEDYNE, INC.

City/State/Country

Corona, CA, US

Establishment Address

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

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TRIMEDYNE, INC. (Owner Number: 9920133)

Owner / Operator Contact Address

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

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K911457

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2002-04-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-03-23
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-11-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-03-23

Official Correspondent

Na Luangchai

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TRIMEDYNE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1419951. Last updated year: 2026. Please use registration number 1419951 when referencing this establishment in official correspondence.