Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009453258

FEI Number

3009453258

Entity Name

International Medical Lasers, Inc.

City/State/Country

Tualatin, OR, US

Establishment Address

18057 Teton Ave, Tualatin, OR 97062, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

International Medical Lasers, Inc./Mooney (Owner Number: 10039842)

Owner / Operator Contact Address

18057 SW Teton Avenue, Tualatin, OR 97062, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231774

PMA Number

N/A

All Registered Proprietary Names

Fiber Dust Opera Evo Cyber Tm Family Scar3 Surgical Laser Fibers Cyber Ho 150 Litho 150 Cyber Blade Scar 3 BubbleView/S-13 Medical Video Endoscope System Litho DK30 Deka Smartxide Trio Litho Litho 60 Cyber Ho 100 Litho 100 Cyber Ho 60 CoralView

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	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-12-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-08-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-08-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-27
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-05-04
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-27

Official Correspondent

John Mooney

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

International Medical Lasers, Inc./Mooney

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-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009453258. Last updated year: 2026. Please use registration number 3009453258 when referencing this establishment in official correspondence.