FDA Registration
Active
🇺🇸 United States
International Medical Lasers, Inc.
Reg #: 3009453258
·
FEI: 3009453258
·
Expires 2026
Products
5
Proprietary Names
30
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- International Medical Lasers, Inc.
- Registration Number
- 3009453258
- FEI Number
- 3009453258
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 18057 Teton Ave
- City
- Tualatin
- State
- OR
- ZIP
- 97062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210142
Owner / Operator
- Firm Name
- International Medical Lasers, Inc./Mooney
- Operator Number
- 10039842
- Address
- 18057 SW Teton Avenue
- City
- Tualatin
- State
- OR
- Postal Code
- 97062
- Country
- US
- Correspondent
- John P Mooney
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-05-04 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-08-06 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2024-12-27 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2023-05-04 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2023-05-04 |
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
Litho EVO
Pusen Eview Medical Video Endoscope Image Processor
Model PV210
PC200-AS
PV300
HD Medical Video Endoscope Image Processor
PC200-R
PC200-S
Pusen Single Use Flexible Video Cystoscope System
PC200-AR
Fiber Dust PRO
Establishment Types
Complaint File Establishment per 21 CFR 820.198