FDA Registration
Active
🇮🇱 Israel
FoLix
Reg #: 3021349626
·
FEI: 3021349626
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Lumenis Be Ltd
- Registration Number
- 3021349626
- FEI Number
- 3021349626
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9 Hakidma St, POB # 426, Yokneam Industrial Park
- City
- Yokneam, Ha Zafon 2069236 Haifa
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K242349
Owner / Operator
- Firm Name
- Lumenis Be Ltd.
- Operator Number
- 10082799
- Address
- 9 Hakidma St, POB # 426, Yokneam Industrial Park
- City
- Yokneam Ha Zafon
- State
- Haifa
- Postal Code
- 2069236
- Country
- IL
- Correspondent
- Shlomit Segman
US Agent
- Business Name
- Lumenis Be Inc
- Contact Name
- Michael Robinson
- Address
- 1870 S Milestone Dr
- City
- Salt Lake City
- State
- UT
- ZIP
- 84104
- Country
- US
- [email protected]
- Phone
- 801 6562574
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2024-10-22 |
Proprietary Names
FoLix
FoLiCool Tip
FoLix Handpiece
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device