FDA Registration
Active
🇮🇱 Israel
FACETITE TURBO
Reg #: 3010511300
·
FEI: 3010511300
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INMODE LTD.
- Registration Number
- 3010511300
- FEI Number
- 3010511300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Tavor Building (POB 533), Shaar Yokneam
- City
- Yokneam Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K240780
Owner / Operator
- Firm Name
- INMODE LTD.
- Operator Number
- 10045478
- Address
- Tavor Building (POB 533), Shaar Yokneam
- City
- Yokneam
- State
- Northern
- Postal Code
- 2069206
- Country
- IL
US Agent
- Business Name
- A.Stein Regulatory Affairs Consulting Company Ltd.
- Contact Name
- Naphtali Deutsch
- Address
- 9559 COLLINS AVE, APARTMENT 1007
- City
- Surfside
- State
- FL
- ZIP
- 33154
- Country
- US
- [email protected]
- Phone
- 888 4433867
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-08-05 |
Proprietary Names
FACETITE TURBO
HP060999A
HP172296A
QUANTUMRF 10
HP172246A
HP253966A
HP101306A
HP1022B6A
HP172248A
INMODE RF PRO (System platform)
BODYTITE TURBO
HP2539B6A
HP060909A
HP101396A
InMode RF System
QUANTUMRF 25
HP172206A
HP102206A
Establishment Types
Manufacture Medical Device