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Quantel Medical Optimis Fusion SLT/YAG laser - HSA Registration DE0506100

Access comprehensive regulatory information for Quantel Medical Optimis Fusion SLT/YAG laser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506100 and owned by Quantel Medical. The device was registered on August 24, 2021.

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
DE0506100
Quantel Medical Optimis Fusion SLT/YAG laser
HSA Registration Number: DE0506100
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Product Description

The OPTIMIS FUSION incorporates two treatment modes and is intended for: - YAG photodisruption mode — to carry out: • posterior capsulotomy • iridotomy • posterior membranectomy - SLT mode — to carry out: • selective Laser Trabeculoplasty (SLT)

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0506100
Registration Date
August 24, 2021
Change Notification Approval Date
July 05, 2022
Retention Due Date
August 23, 2025
Product Owner
Short Name
Quantel Medical
Address
1, rue du bois joli, CS 40015, 63808 Cournon d’Auvergne Cedex, FRANCE
Registrant
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Address
2 KALLANG AVENUE, CT HUB, #09-19, SINGAPORE 339407 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
Optimis Fusion
Model Identifier(s)
FUSION