FDA Registration
Active
🇮🇱 Israel
InMode VLaze
Reg #: 3010511300
·
FEI: 3010511300
·
Expires 2025
Products
1
Proprietary Names
3
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
- K173677
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 |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2018-02-27 |
Proprietary Names
InMode VLaze
TRITON/ OPTIMAS (system platform)
Vasculaze
Establishment Types
Manufacture Medical Device