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Fotona AvalancheLase Laser Systems - HSA Registration DE0509630

Access comprehensive regulatory information for Fotona AvalancheLase Laser Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509630 and owned by Fotona d.o.o. The device was registered on August 06, 2024.

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
DE0509630
Fotona AvalancheLase Laser Systems
HSA Registration Number: DE0509630
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Product Description

The AvalancheLase laser systems family is intended to be used in the fields of aesthetics and dermatology using Nd:YAG laser for the following indications: • Treatment of mild to moderate inflammatory acne vulgaris • Verrucae and warts • Temporary increase of clear nail in patients with onychomycosis

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0509630
Registration Date
August 06, 2024
Retention Due Date
August 05, 2025
Product Owner
Short Name
Fotona d.o.o
Address
Stegne 7, 1000 Ljubljana, SLOVENIA
Registrant
Address
111 NORTH BRIDGE ROAD, PENINSULA PLAZA, #21-01, SINGAPORE 179098
Importer
Address
1004 TOA PAYOH NORTH, #06-10, SINGAPORE 318995
Model Information
Model Name(s)
Handpiece R35X Handpiece R35X- S11 LX Runner AvalancheLase AvalancheLase
Model Identifier(s)
103376 107656 111087 M071-2F/LXP M071-2F/XP