Singapore HSA registration DE0016952
Lutronic Spectra XT Laser System
Singapore·CLASS C·Lutronic Corporation·Registered March 17, 2015Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C