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Lutronic AccuSculpt Laser System - HSA Registration DE0007520

Access comprehensive regulatory information for Lutronic AccuSculpt Laser System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007520 and owned by Lutronic Corporation. The device was registered on August 31, 2011.

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
DE0007520
Lutronic AccuSculpt Laser System
HSA Registration Number: DE0007520
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Product Description

Indicated for use in laser-assisted lipolysis.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90132000
Registration Information
Registration Number
DE0007520
Registration Date
August 31, 2011
Change Notification Approval Date
March 22, 2024
Retention Due Date
August 30, 2025
Product Owner
Short Name
Lutronic
Address
#403/404 Ilsan Techno Town 1141-1, Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Address
19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Importer
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263 50 UBI AVENUE 3, FRONTIER, #05-09, SINGAPORE 408866
Model Information
Model Name(s)
Cannula Handpiece Handpiece Optical Fiber Accsculpt Machine
Model Identifier(s)
1010800100 3010618500 3010622400 3203200700 Accusculpt