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LHbiomed Ultrasonic Surgical Unit - HSA Registration DE0510359

Access comprehensive regulatory information for LHbiomed Ultrasonic Surgical Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510359 and owned by LHbiomed Co., Ltd.. The device was registered on February 20, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0510359
LHbiomed Ultrasonic Surgical Unit
HSA Registration Number: DE0510359
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Product Description

LS- 1000/ LS-2000 are intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy) and treatment of diseases caused by fat such as osmidrosis axillae and gynecomastia. LS- 1000/ LS-2000 are also indicated for use in the following surgical specialties when the fragmentation and emulsifications of soft tissues: plastic and reconstructive surgery and orthopedic surgery. They are capable of powering instruments for soft tissue dissection and coagulation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510359
Registration Date
February 20, 2025
Retention Due Date
February 19, 2026
Product Owner
Short Name
LHbiomed Co., Ltd.
Address
#806 Medical Device Complex Center, 200 Gieopdosi-ro, Jijeong-myeon, Wonju-si, Gangwon-do, KOREA, REPUBLIC OF
Registrant
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Importer
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model Information
Model Name(s)
Hand piece Ultrasonic Surgical Unit Ultrasonic Surgical Unit Probes Probes Probes
Model Identifier(s)
L01-AS-HPAS-001 LS-1000 LS-2000 PB-109-001 PB-209-001 PB-307-001