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Singapore HSA registration DE0018938

Candela elos Plus System

Singapore flagSingapore·CLASS C·Candela Corporation·Registered February 06, 2017
Device classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0018938
Registration Date
February 06, 2017
Change Notification Approval Date
November 01, 2023
Retention Due Date
February 05, 2026
Product description
The elos Plus Skin Treatment system is intended for the following applications: Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, treatment of facial wrinkles, treatment of striae and treatment of acne scars. Motif IR/Matrix IR/Sublime applicator is indicated for non-invasive wrinkle treatment. LV/LVA Applicator is indicated for vascular lesions treatment. SR/SR Plus/SRA/SRA Plus/SRA Mini Applicator is indicated for superficial benign pigmented and vascular lesions treatment. AC Applicator is indicated for acne treatment. Motif HR/DS/Motif HR Plus/Motif LHR/DSL/Motif Vantage is indicated for the removal of unwanted hair from skin types I to VI and to affect stable long term, or permanent, hair reduction.
Product Owner
Name
Candela Corporation
Short Name
Candela Corporation
Address
251 Locke Drive, Marlborough, MA 01752, UNITED STATES
Registrant
Name
SONAX BUSINESS SOLUTIONS
Address
100 PECK SEAH STREET, PS100, #08-14, SINGAPORE 079333
Importer
Name
NEOASIA (S) PTE LTD
Address
6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Model information
Model Name(s)
elos Plus (console ) Sublative RF Applicator AC Applicator DS Applicator SR Applicator SRA Applicator Sublime Applicator DSL Applicator LV Applicator LVA Applicator Matrix IR Applicator MOTIF LHR Applicator Motif IR Applicator Motif HR Applicator Motif HR Plus Applicator SR Plus Applicator SRA Plus Applicator SRA Mini Applicator Motif Vantage Applicator Sublative RF Tips Sublative RF Tips
Model Identifier(s)
FG70534 FG70541 FG70591 FG70601 FG70611 FG70621 FG70631 FG70641 FG70661 FG70671 FG70681 FG70871 FG70911 FG70921 FG71061 FG71131 FG71141 FG71151 FG71281 KT7293X KT7296X
About this record

Access comprehensive regulatory information for Candela elos Plus 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 DE0018938 and owned by Candela Corporation. The device was registered on February 06, 2017.

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