Sharplight Technologies Ltd.
RISHON LEZION Tel Aviv, IL
SHARPLIGHT TECHNOLOGIES LTD. appears in FDA device records in RISHON LEZION Tel Aviv, IL. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Sharplight Technologies Ltd. between 2008 and 2023. The busiest year on record is 2008, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2011 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233304 | Omnimax S3, Omnimax S4 | GEX | Substantially Equivalent | |
| K173169 | Rapid Family | GEX | Substantially Equivalent | |
| K111303 | DERMATOLOGICAL TREATMENT DEVICE FAMILY | GEX | Substantially Equivalent | |
| K082876 | BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006716777 | 3006716777 | SHARPLIGHT TECHNOLOGIES LTD. | 33 lazarov st., RISHON LEZION Tel Aviv 7565435 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NUVMassager, Vacuum, Light Induced Heating
- GEXPowered Laser Surgical Instrument
- ONGPowered Laser Surgical Instrument With MicrobeamFractional Output
- ONEPowered Light Based Non-Laser Surgical Instrument
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain