LUMENIS, LTD.

FDA Device Registration & Listing · YOKNEAM Northern, IL · Registration 3004135191

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
3004135191
FEI Number
3004135191
Entity Name
LUMENIS, LTD.
City/State/Country
YOKNEAM Northern, IL
Establishment Address
6 HAKIDMA STREET PO BOX 240, YOKNEAM INDUSTRIAL PARK, YOKNEAM Northern 2069204, IL
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Boston Scientific Corporation (Owner Number: 9912058)
Owner / Operator Contact Address
300 Boston Scientific Way, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252529
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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 2021-10-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-10-08
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-10-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-06-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-10-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-10-08
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-01-15

Official Correspondent

Adrienne Bishop

US Agent Details

Aaron Dunbar Email: aaron.dunbar@bsci.com Phone: (651) 3961414

Related Public Records

Same Entity

Boston Scientific Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3025434462 Obsidio Inc Maple Grove, MN, US
3005619880 Boston Scientific Corporation Roswell, GA, US
3015425075 NALU MEDICAL Carlsbad, CA, US
3015289131 FARAPULSE, INC. Menlo Park, CA, US
3022298579 Boston Scientific Cardiac Diagnostic Technologies, Inc. Arden Hills, MN, 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-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Similar Registrations

Registration Number Establishment Name Location
3014980477 ELEMENIC CO., LTD. Seoul, KR
3009462521 Oncore Manufacturing, LLC dba NEOTech Fremont, CA, US
3033905238 BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD. Beijing, CN
3014384451 LAMEDITECH CO., LTD. Seoul, KR
3010273372 WEIFANG KM ELECTRONICS CO., LTD Weifang Shandong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004135191. Last updated year: 2026. Please use registration number 3004135191 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.