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Classys Fraxis DUO CO2 Laser System - HSA Registration DE0510622

Access comprehensive regulatory information for Classys Fraxis DUO CO2 Laser 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 DE0510622 and owned by CLASSYS Inc.. The device was registered on April 24, 2025.

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
DE0510622
Classys Fraxis DUO CO2 Laser System
HSA Registration Number: DE0510622
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Product Description

The FRAXIS DUO system’s CO2 laser system is intended to use in general and plastic surgery and in dermatology. Specific indication: Surgical mode - warts

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0510622
Registration Date
April 24, 2025
Retention Due Date
April 23, 2026
Product Owner
Short Name
CLASSYS Inc.
Address
208, Teheran-ro, Gangnam-gu, Seoul, 06220, Republic of Korea, KOREA, REPUBLIC OF
Registrant
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Importer
Address
38 JALAN PEMIMPIN, M38, #07-06, SINGAPORE 577178
Model Information
Model Name(s)
Classys Fraxis DUO CO2 Laser System
Model Identifier(s)
FRX-C2