FDA Registration
Active
🇮🇱 Israel
Laser Diode Therapy System
Reg #: 3030125922
·
FEI: 3030125922
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- K.P. IMPULS LTD.
- Registration Number
- 3030125922
- FEI Number
- 3030125922
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 27 Lishansky Street
- City
- Rishon Le Zion Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K192569
Owner / Operator
- Firm Name
- K.P. Impuls Ltd.
- Operator Number
- 10089471
- Address
- 27 Lishansky Street
- City
- Rishon Le Zion
- State
- IL-NOTA
- Postal Code
- 7565040
- Country
- IL
- Correspondent
- Igor Chertin
US Agent
- Business Name
- Medicsense USA LLC
- Contact Name
- George Hattub
- Address
- 291 Hillside Ave
- City
- Somerset
- State
- MA
- ZIP
- 02726
- Country
- US
- [email protected]
- Phone
- 508 4796116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-12-11 |
Proprietary Names
Laser Diode Therapy System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)