FDA Registration
Active
🇺🇸 United States
HD Medical Video Endoscope Image Processor
Reg #: 3009453258
·
FEI: 3009453258
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- International Medical Lasers, Inc.
- Registration Number
- 3009453258
- FEI Number
- 3009453258
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 18057 Teton Ave
- City
- Tualatin
- State
- OR
- ZIP
- 97062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222602
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 |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2023-05-04 |
Proprietary Names
HD Medical Video Endoscope Image Processor
PV300
PC200-AR
Pusen Single Use Flexible Video Cystoscope System
PC200-AS
PC200-S
PC200-R
Establishment Types
Complaint File Establishment per 21 CFR 820.198