Singapore HSA registration DE0509630
Fotona AvalancheLase Laser Systems
Singapore·CLASS C·Fotona d.o.o·Registered August 06, 2024Device 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 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
Product Owner
- Name
- Fotona d.o.o
- 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
About this record
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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