FDA Registration
Active
🇮🇱 Israel
ENDYMED MEDICAL LTD
Reg #: 3008085016
·
FEI: 3008085016
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- ENDYMED MEDICAL LTD
- Registration Number
- 3008085016
- FEI Number
- 3008085016
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12 Leshem Street, North Industrial Park
- City
- Caesarea Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K130793
Owner / Operator
- Firm Name
- Endymed Medical Ltd
- Operator Number
- 10030976
- Address
- 12 Leshem Street, North Industrial Park
- City
- Caesarea
- State
- Northern
- Postal Code
- 3088900
- Country
- IL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-12-24 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-11-12 |
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2025-07-31 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2025-07-31 |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | Class 2 | General, Plastic Surgery | No | 2016-11-23 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2017-02-08 |
Proprietary Names
NEWA
PURE Laser with EPL810 HP
PRO MAX system with Small MAX HP, mini-Shaper MAX HP, Shaper MAX HP,
iFine MAX HP, FSR MAX HP , Intensif MAX HP, Contour MAX HP
NEWA/NEWA+
PURE 2 system with Small HP, iFine HP, mini-shaper HP, Shaper HP
EndyGel
Intensif HP
Contour Handpiece
FSR Handpiece
EndyMed PRO system with Small HP, iFine HP, mini-Shaper HP, Shaper HP
Establishment Types
Manufacture Medical Device