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Singapore HSA registration DE0501671

Fotona StarWalker Laser System

Singapore flagSingapore·CLASS C·Fotona d.o.o·Registered May 25, 2018
Device classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0501671
Registration Date
May 25, 2018
Change Notification Approval Date
September 14, 2021
Retention Due Date
May 24, 2025
Product description
The Fotona StarWalker laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization of soft tissue in general dermatology.
Product Owner
Name
Fotona d.o.o
Short Name
Fotona d.o.o
Address
Stegne 7, 1000 Ljubljana, SLOVENIA
Registrant
Name
SERVICOM MEDICAL (SINGAPORE) PTE LTD
Address
140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Importer
Name
SERVICOM MEDICAL (SINGAPORE) PTE LTD
Address
140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Model information
Model Name(s)
Footswitch LW Wireless Footswitch Receiver LW Footswitch wireless LW R 29 d R 650 d R 585 d FS 20 d FS 20A d FS 50 d R 28 d R 58 d Wireless Footswitch Transmitter 2 LW FS 20B d FS 50B d FS 20C d StarWalker Fotona QX Max M031-3A/2 MAQX StarWalker Fotona QX Max M031-3A/2 QX
Model Identifier(s)
87593 88301 89199 92167 95861 95879 96026 96027 96028 96033 96035 96867 98738 98739 98740 99166 99167
About this record

Access comprehensive regulatory information for Fotona StarWalker 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 DE0501671 and owned by Fotona d.o.o. The device was registered on May 25, 2018.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C