Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021349626

FEI Number

3021349626

Entity Name

Lumenis Be Ltd

City/State/Country

Yokneam, Ha Zafon 2069236 Haifa, IL

Establishment Address

9 Hakidma St, POB # 426, Yokneam Industrial Park, Yokneam, Ha Zafon 2069236 Haifa 2069236, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Lumenis Be Ltd. (Owner Number: 10082799)

Owner / Operator Contact Address

9 Hakidma St, POB # 426, Yokneam Industrial Park, Yokneam Ha Zafon, IL-HA 2069236, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN200028

PMA Number

N/A

All Registered Proprietary Names

OPT Shields SurgiTouch Scanning Handpiece 125mm FemTouch Disposable Tips AcuPulse CO2 Laser System AcuScan 120 Microscanner SurgiTouch Scanner SurgiTouch Scanning Handpiece Set AcuPulse Incisional Handpiece 125 mm FemX handpieces SurgiTouch Scanning Handpiece 260mm AcuPulse Upgrade Kit 40 to 40AES-F FemTouch SurgiTouch Scanning Handpiece 200mm AcuPulse Upgrade Kit 40 to 40AES-R AcuPulse Upgrade Kit 40AES-F to 40AES-R UltraPulse Encore DeepFX Microscanner UltraScan CPG Focused Incisional Handpiece Set TrueSpot Collimated 2 mm Handpiece FoLiCool Tip FoLix FoLix Handpiece M22 Universal IPL Filter Kit M22 Q-Switched Nd:YAG Upgrade Kit Universal IPL SapphireCool Light Guides Universal IPL Expert filters M22 IPL handpiece M22 Universal IPL treatment head ResurFX System Handpiece M22 Multi-Spot Nd:YAG Upgrade Kit Universal IPL Treatment Head Focused Incisional Handpiece Set DeepFX Microscanner FemTouch reusable tips Ultrascan CPG Scanner FemTouch Adaptor kit UltraPulse Alpha Office DeepFX Disposable Tip UltraPulse Alpha OR TrueSpot Collimated 2 mm Handpiece FemTouch Disposable Tips FemX Adaptor kit DeepFX Air Disposable Tip FemX Disposable tips OptiLight IPL Upgrade Kit Stellar M22 Q-switched Nd:YAG upgrade kit Steller M22 WIZ LMX System M22 Q-Switched Head Stellar M22 IPL handpiece Stellar M22 IPL filters Stellar M22 Steller M22 vascular filter Stellar M22 Acne filter Stellar M22 IPL LightGuides OptiLight IPL Handpiece Stellar M22 accessory kit Stellar M22 calibration filter M22 Nd:YAG Head OptiLight Nd:YAG LightGuides Stellar M22 ResurFX Module Upgrade Kit M22 Q-Switched Lens & Metal Treatment Tip Kit Stellar M22 RFX system OptiLight Aesthetics M22 Q-Switched Nd:YAG Tips ResurFX Tips ResurFX Head Stellar M22 AES IPL Module Kit M22 Q-Switched Lens Digital OptiLight Aesthetic Stellar M22 Multi-Spot Nd:YAG Upgrade kit Digital OptiLight FoLiCool Tip FoLix FoLix Handpiece - spare part FoLix Handpiece LightSheer 805 HS Handpiece LightSheer 805 XC Handpiece LightSheer DESIRE LightSheer Desire Light LightSheer 1060 ET Handpiece LightSheer QUATTRO LightSheer Duet ET Handpiece LightSheer 1060 XC Handpiece LightSheer 805 ET Handpiece High-Speed Disposables Kit LightSheer 1060 HS Handpiece LightSheer Duet HS Handpiece LightSheer Duet Laser System OptiLight Accessories Kit Stellar M22 IPL Upgrade Kit for OptiLight OptiLight IPL Handpiece OptiLight IPL Module Kit Opti-Tip Pack OptiLight OPT Module Kit OPT Handpiece OptiLight Aesthetic OptiLight IPL Modality Filters Kits OptiLight Filter Opti-Tip Digital OptiLight Aesthetic OptiLight AES General Accessories Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-12-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2022-01-17
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-10-22
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2024-10-22
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2024-10-22
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2021-10-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-10
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2021-10-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-12-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-10
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2021-10-10
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2021-10-10
OAP	Laser, Comb, Hair	Physical Medicine	Class 2	890.5500	2024-01-21
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-10
QIU	Intense Pulsed Light Device For Managing Dry Eye	Ophthalmic	Class 2	886.5201	2021-10-10

Official Correspondent

Shlomit Segman

US Agent Details

Michael Robinson Business: Lumenis Be Inc Email: michael.robinson@lumenis.com Phone: (801) 6562574

Related Public Records

Same Entity

Lumenis Be Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020611964	LUMENIS BE INC.	Salt Lake City, UT, US

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, PASLT Fiber Delivery SystemSterileNon-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021349626. Last updated year: 2026. Please use registration number 3021349626 when referencing this establishment in official correspondence.