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Lutronic Spectra XT Laser System - HSA Registration DE0016952

Access comprehensive regulatory information for Lutronic Spectra XT 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 DE0016952 and owned by Lutronic Corporation. The device was registered on March 17, 2015.

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
DE0016952
Lutronic Spectra XT Laser System
HSA Registration Number: DE0016952
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Product Description

The Spectra XT Machine is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; epidermal pigmented lesions(Freckles, Solar Lentigines, Café-au-lait), epidermal & dermal pigmented lesions(Melasma), dermal pigmented lesions(Nevus of Ota&Ito, ABNOM or Hori’s nevus), Telangiectasia, Removal of minor vascular lesions, Acne, Traumatic tattoo, Erythema.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0016952
Registration Date
March 17, 2015
Change Notification Approval Date
January 23, 2024
Retention Due Date
March 16, 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)
1064 Fractional Handpiece 10mm-Zoom-Collimated Handpiece 2mm-SD585 Handpiece 2mm-SD650 Handpiece 532 Fractional Handpiece Foot switch Gold Toning Handpiece RuVY Touch Handpiece Spectra XT Machine
Model Identifier(s)
1064 Fractional Handpiece 10mm-Zoom-Collimated Handpiece 2mm-SD585 Handpiece 2mm-SD650 Handpiece 532 Fractional Handpiece Foot switch Gold Toning Handpiece RuVY Touch Handpiece Spectra XT machine