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Lutronic Healite II - HSA Registration DE0501283

Access comprehensive regulatory information for Lutronic Healite II in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501283 and owned by Lutronic Corporation. The device was registered on February 23, 2018.

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
DE0501283
Lutronic Healite II
HSA Registration Number: DE0501283
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Product Description

The Lutronic HEALITE II system offers 6 treatment heads: 830nm/590nm, 830nm/590nm & 633nm, 830nm/590nm & 415nm and 633nm & 415nm, 633nm, 415nm, for: (1) Wound Healing (2) Pain relief (3) Acne treatment

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501283
Registration Date
February 23, 2018
Change Notification Approval Date
January 23, 2024
Retention Due Date
February 22, 2026
Product Owner
Short Name
Lutronic Corporation
Address
Lutronic Center, 219 Sowon-ro, Deogyang-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)
Power Supply LCD control screen Head 633nm Head 415 nm Head 633 nm & 415 nm Head 830 nm/590 nm & 633nm Head 830 nm/590 nm & 415nm Head 830 nm/590 nm HEALITE II
Model Identifier(s)
3071200201 3101400614 6070402001 6070402002 6070402003 6070402004 6070402005 6070402006 HEALITE II