Data / Medical devices / Israel / Sharplight Technologies Ltd.
Sharplight Technologies Ltd.: FDA-registered device maker in RISHON LEZION Tel Aviv, Israel, 3 510(k) clearances
Sharplight Technologies Ltd. is registered with the FDA (registration 3006716777) in RISHON LEZION Tel Aviv, Israel. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006716777
- Address
- 33 lazarov st., RISHON LEZION Tel Aviv, Israel, 7565435
- Owner or operator
- SharpLight Technologies Ltd. (9094019)
- Roles
- Manufacturer
- First device listed
- April 22, 2012
- Registered through
- 2026
- Brand names listed
- Beamax, Formax, Omnimax S3, Omnimax S3 (Dermatologic Treatment Systems), Omnimax S4, Omnimax S4 (Dermatologic Treatment Systems), Rapid DPC, Rapid Peel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument | ONE | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2023 | K233304 | Omnimax S3, Omnimax S4 | GEX | Substantially Equivalent | Sharplight Technologies, Ltd. | accessdata.fda.gov |
| November 20, 2017 | K173169 | Rapid Family | GEX | Substantially Equivalent | Sharplight Technologies, Ltd. | accessdata.fda.gov |
| December 21, 2011 | K111303 | DERMATOLOGICAL TREATMENT DEVICE FAMILY | GEX | Substantially Equivalent | Sharplight Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Vacuum, Light Induced Heating
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument With MicrobeamFractional Output
- All makers of Powered Light Based Non-Laser Surgical Instrument
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated December 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.