Singapore HSA registration DE0509167
Cynosure Tempsure System
Singapore·CLASS C·Cynosure LLC·Registered April 12, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0509167
- Registration Date
- April 12, 2024
- Retention Due Date
- April 11, 2026
Product description
The 18mm, 25mm, 30mm, 60mm Smart Handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain and muscle spasms. The following surgical modes are applicable to the generator. Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed.
Product Owner
- Name
- Cynosure LLC
- Short Name
- Cynosure LLC
- Address
- 5 Carlisle Road, Westford, MA 01886, Westford, MA, UNITED STATES
Registrant
- Address
- 19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Importer
- Address
- 19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Model information
- Model Name(s)
- ASSY, GRIP, HANDPIECE, TEMPSURE ASSY, FINAL TempSure, System TempSure Starter Kit ASSY, Body Accessory Kit, Tempsure ASSY, 25MM Handpiece, Tempsure ASSY, 30MM Handpiece, Tempsure ASSY, Probe, Single, Vitalia ASSY, Probe Kit, 5 Pack, Vitalia ASSY, Handpiece Kit, Vitalia ASSY, Vitalia Kit TempSure System ASSY, Handpiece, 60mm Tempsure ASSY, 60mm Body Accessory kit, Tempsure
- Model Identifier(s)
- 100-7027-005 100-7027-010 100-7027-060 100-7027-070 100-7027-125 100-7027-130 100-7037-001 100-7037-100 100-7037-200 100-7037-300 105-7027-000 ASY-12745 ASY-12944
About this record
Access comprehensive regulatory information for Cynosure Tempsure 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 DE0509167 and owned by Cynosure LLC. The device was registered on April 12, 2024.
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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