Lumenis Be Ltd

Registration Details

Registration Name: Lumenis Be Ltd
Registration Number: 3021349626
FEI Number: 3021349626
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 9 Hakidma St, POB # 426, Yokneam Industrial Park
City: Yokneam, Ha Zafon 2069236 Haifa
Country: IL

Regulatory Submissions

510(k) Number: K212703

Owner / Operator

Firm Name: Lumenis Be Ltd.
Operator Number: 10082799
Address: 9 Hakidma St, POB # 426, Yokneam Industrial Park
City: Yokneam Ha Zafon
State: Haifa
Postal Code: 2069236
Country: IL
Correspondent: Shlomit Segman

US Agent

Business Name: Lumenis Be Inc
Contact Name: Michael Robinson
Address: 1870 S Milestone Dr
City: Salt Lake City
State: UT
ZIP: 84104
Country: US
Email: [email protected]
Phone: 801 6562574

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	Class 1	Ophthalmic	No	2022-12-12
Powered Laser Surgical Instrument	GEX	Class 2	General, Plastic Surgery	No	2022-01-17
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	Class 2	General, Plastic Surgery	No	2024-10-22
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	Class 2	General, Plastic Surgery	No	2024-10-22
Laser, Comb, Hair	OAP	Class 2	Physical Medicine	No	2024-01-21
Intense Pulsed Light Device For Managing Dry Eye	QIU	Class 2	Ophthalmic	No	2021-10-10

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 FemTouch reusable tips Ultrascan CPG Scanner FemTouch Adaptor kit UltraPulse Alpha Office DeepFX Disposable Tip UltraPulse Alpha OR 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 FoLix Handpiece - spare part 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 IPL Upgrade Kit for OptiLight OptiLight IPL Module Kit Opti-Tip Pack OPT Module Kit OPT Handpiece OptiLight Aesthetic OptiLight IPL Modality Filters Kits OptiLight Filter Opti-Tip OptiLight AES General Accessories Kit Stellar M22 WIZ LMX System Black Stellar XPL HP Stellar XPL Module Kit Stellar M22 vascular filter SurgiTouch" Scanning Handpiece 125mm, Anodized Aluminum AcuPulse W Laser System

Establishment Types

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