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Candela Nordlys System - HSA Registration DE0503800

Access comprehensive regulatory information for Candela Nordlys 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 DE0503800 and owned by Candela Corporation. The device was registered on November 08, 2019.

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
DE0503800
Candela Nordlys System
HSA Registration Number: DE0503800
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Product Description

Nordlys is intended to be used for medical treatment of changes in the anatomy or of a physiological process in the skin such as treatment of Actinic keratosis, Temporary increase of clear nail in patients with onychomycosis, Mild or Moderate (Non- Cystic) Inflammatory Acne Vulgaris and Benign Cutaneous Warts (Incision, Excision, and Coagulation) including: Periungual, Subungual Warts, Plantar Wartsโ€™

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503800
Registration Date
November 08, 2019
Change Notification Approval Date
June 07, 2022
Retention Due Date
November 07, 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
6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Model Information
Model Name(s)
Contact Gel, 5 x 250 ml Contact Gel, 5 liter HR 600 applicator HR 600 Applicator HRL 600 applicator HRL 600 Applicator HRD 645 applicator HRD 645 Applicator VL 555 applicator VL 555 Applicator PR 530 applicator PR 530 Applicator PL 400 applicator PL 400 Applicator Nd:YAG applicator Nd:YAG Applicator VLS 555 applicator ย ย ย  VLS 555 Applicator ย ย ย  PRS 530ย applicator PRS 530ย Applicator Frax 1940 Applicator Ellipse nordlys Nordlys
Model Identifier(s)
2GEL0826 2GEL1342 9APP7744 9APP7744-CNDL 9APP7745 9APP7745-CNDL 9APP7746 9APP7746-CNDL 9APP7747 9APP7747-CNDL 9APP7748 9APP7748-CNDL 9APP7749 9APP7749-CNDL 9APP7750 9APP7750-CNDL 9APP7814 9APP7814-CNDL 9APP7815 9APP7815-CNDL 9APP7908 9SYS7751 9SYS7751-CNDL