SHARPLIGHT TECHNOLOGIES LTD.

FDA Device Registration & Listing · RISHON LEZION Tel Aviv, IL · Registration 3006716777

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006716777
FEI Number
3006716777
Entity Name
SHARPLIGHT TECHNOLOGIES LTD.
City/State/Country
RISHON LEZION Tel Aviv, IL
Establishment Address
33 lazarov st., RISHON LEZION Tel Aviv 7565435, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SharpLight Technologies Ltd. (Owner Number: 9094019)
Owner / Operator Contact Address
33 Lazarov St., --, Rishon Le'Zion, IL-M 7565435, IL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K111303
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-01-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-01-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-06
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2024-02-06
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2024-02-06
ONE Powered Light Based Non-Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-06
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2024-02-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-04-22

Official Correspondent

Yura Isacov

US Agent Details

Tania Marie Amar Email: taniamarieamar@gmail.com Phone: (786) 2014663

Related Public Records

Same Entity

SharpLight Technologies Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006716777. Last updated year: 2026. Please use registration number 3006716777 when referencing this establishment in official correspondence.
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