HSA · registration DE0509380Candela Profound Matrix™ System
SingaporeRadiology / ImagingClass CCandela Corporation
Official record identity
- Registration number
- DE0509380
- Model name
- Matrix Pro™ Cartridge Trip; Focal 44 Sublative iD (200 Pulses); Standard 64 Sublative iD (200 Pulse); Profound Matrix™; Matrix Pro™ Applicator, Profound Matrix™; Sublative™ RF Applicator, Profound Matrix™; Standard 64 Sublative iD, (100 Pulse), 10-Pk; Standard 64 Sublative iD, (100 Pulse); Standard 64 Sublative iD, (400 Pulse), 10-Pk; Standard 64 Sublative iD, (400 Pulse); Matrix Pro™ Cartridge Box, Pack of 7; Standard 64 Sublative iD, (200 Pulse), 10-Pack; Focal 44 Sublative iD, (200 Pulse), 10-Pack
- Model identifier
- AS09627; AS96121; AS96122; FG71841; FG71851; FG71861; FIN100253; FIN100271; FIN100272; FIN100273; KT78161; KT78226; KT78227
- Registration date
- June 11, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Candela Corporation
- Registrant / registration holder
- SONAX BUSINESS SOLUTIONS
Official description
The Sublative RF applicator is indicated for dermatological procedures requiring ablation. The Matrix Pro applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis.
Additional source fields
- Product owner address
- 251 Locke Drive, Marlborough, MA 01752, United States
- Registrant address
- 100 PECK SEAH STREET, #08-14, PS100, Singapore 079333
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.