Omnimax S3, Omnimax S4
Sharplight Technologies, Ltd.
SHARPLIGHT TECHNOLOGIES LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006716777 | 3006716777 | SHARPLIGHT TECHNOLOGIES LTD. | 1 | N | 2026-01-01 | 33 lazarov st. RISHON LEZION Tel Aviv IL 7565435 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 72563 | 1551020431 | K233304 | Omnimax S3, Omnimax S4 | GEX | 2023-12-22 |
| 72563 | 1928731535 | K173169 | Rapid Family | GEX | 2017-11-20 |
| 72563 | 1121942877 | K111303 | DERMATOLOGICAL TREATMENT DEVICE FAMILY | GEX | 2011-12-21 |
| 72563 | 1191604461 | K063249 | BEAMAX | GEX | 2007-01-17 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEX | 6 | 2023-12-22 |
PMN#
Rapid Family
SharpLight Technologies Ltd.
DERMATOLOGICAL TREATMENT DEVICE FAMILY
SHARPLIGHT TECHNOLOGIES LTD.
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
SHARPLIGHT TECHNOLOGIES LTD.
GUDID#
OMNIMAX S3 - The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, includingIntensive Pulse Light (IPL) and Infrared light (IR) for dermatologicaltreatments by delivery of energy to the human skin.
2023-05-21
OMNIMAX S4 - The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared light (IR) and Laser light technologies for dermatological treatments by delivery of energy to the human skin.
2023-05-21
Rapid Peel - RAPID–PEEL
2023-05-22
Rapid Vanish - RAPID-VANISH
2023-05-22
Rapid QS - RAPID-QS
2023-05-22
Rapid Tight - RAPID–TIGHT
2023-05-22
Rapid DPC - RAPID-DPC
2023-05-22