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Candela Profound Matrix™ System - HSA Registration DE0509380

Access comprehensive regulatory information for Candela Profound Matrix™ 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 DE0509380 and owned by Candela Corporation. The device was registered on June 11, 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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CLASS C
DE0509380
Candela Profound Matrix™ System
HSA Registration Number: DE0509380
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Product 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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509380
Registration Date
June 11, 2024
Retention Due Date
June 10, 2025
Product Owner
Short Name
Candela Corporation
Address
251 Locke Drive, Marlborough, MA 01752, UNITED STATES
Registrant
Address
100 PECK SEAH STREET, PS100, #08-14, SINGAPORE 079333
Importer
Address
101 Upper Cross Street, People's Park Centre, #05-54, SINGAPORE 058357
Model Information
Model Name(s)
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(s)
AS09627 AS96121 AS96122 FG71841 FG71851 FG71861 FIN100253 FIN100271 FIN100272 FIN100273 KT78161 KT78226 KT78227