FDA Registration
Active
🇮🇱 Israel
SHARPLIGHT TECHNOLOGIES LTD.
Reg #: 3006716777
·
FEI: 3006716777
·
Expires 2026
Products
6
Proprietary Names
12
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SHARPLIGHT TECHNOLOGIES LTD.
- Registration Number
- 3006716777
- FEI Number
- 3006716777
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 33 lazarov st.
- City
- RISHON LEZION Tel Aviv
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K173169
Owner / Operator
- Firm Name
- SharpLight Technologies Ltd.
- Operator Number
- 9094019
- Address
- 33 Lazarov St., --
- City
- Rishon Le'Zion
- State
- Central
- Postal Code
- 7565435
- Country
- IL
- Correspondent
- Yura - Isacov
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2018-01-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-01-29 |
| Massager, Vacuum, Light Induced Heating | NUV | Class 2 | General, Plastic Surgery | No | 2024-02-06 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2024-02-06 |
| Powered Light Based Non-Laser Surgical Instrument | ONE | Class 2 | General, Plastic Surgery | No | 2024-02-06 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2024-02-06 |
Proprietary Names
Rapid Peel
Rapid DPC
Rapid QS
Rapid Vanish
Rapid Tight
Rapid Smooth
Omnimax S3
Omnimax S4
Formax
Omnimax S3 (Dermatologic Treatment Systems)
Omnimax S4 (Dermatologic Treatment Systems)
Beamax
Establishment Types
Manufacture Medical Device