Singapore HSA registration DE0503800
Candela Nordlys System
Singapore·CLASS C·Candela Corporation·Registered November 08, 2019Device 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 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 Warts’
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 VLS 555 Applicator PRS 530 applicator PRS 530 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
About this record
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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