Cynosure Lutronic Technology Corporation

FDA Device Registration & Listing · Goyang Gyeonggi, KR · Registration 3033511105

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
3033511105
FEI Number
3033511105
Entity Name
Cynosure Lutronic Technology Corporation
City/State/Country
Goyang Gyeonggi, KR
Establishment Address
55 Samwon-Ro, Deogyang, Goyang Gyeonggi 10550, KR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Lutronic Aesthetics, Inc. (Owner Number: 9058403)
Owner / Operator Contact Address
3/5 Carlisle Road, Westford, MA 01886, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PicoSure Workstation CLARITY II Laser System PICOPLUS Laser System MOSAIC 3D HEALITE II PicoSure Pro

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 2025-09-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-08-20
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-07-30
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2024-02-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-05
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2013-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-09-18

Official Correspondent

Sean Reynolds

US Agent Details

Sean Reynolds Business: Cynosure LLC Email: sean.reynolds@cynosurelutronic.com Phone: (978) 8429864

Related Public Records

Same Entity

Lutronic Aesthetics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3043532708 Cynosure Lutronic Technology Corporation Daegu Gyeongbuk, KR
3006247712 Lutronic Aesthetics, Inc. Westford, MA, US
3023706404 Lutronic Corporation Daegu Gyeongbuk, KR
3013789508 Lutronic Corporation Goyang-si Gyeonggi, KR
3004483538 LUTRONIC CORPORATION Goyang-si Gyeonggi, KR

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

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 3033511105. Last updated year: 2026. Please use registration number 3033511105 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.