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Lutronic eCO2 Plus Fractional CO2 Laser - HSA Registration DE0502860

Access comprehensive regulatory information for Lutronic eCO2 Plus Fractional CO2 Laser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502860 and owned by Lutronic Corporation. The device was registered on March 12, 2019.

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
DE0502860
Lutronic eCO2 Plus Fractional CO2 Laser
HSA Registration Number: DE0502860
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Product Description

The eCO2 Plus laser system can be applied to any of the following applications: Warts, Syringoma, Various surgical procedures requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in medical specialties including: snoring, phimosis and hemorrhoids.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0502860
Registration Date
March 12, 2019
Change Notification Approval Date
January 23, 2024
Retention Due Date
March 11, 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
Model Information
Model Name(s)
eCO2 Plus
Model Identifier(s)
1040200800