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Fotona SP Spectro Laser System - HSA Registration DE0501762

Access comprehensive regulatory information for Fotona SP Spectro 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 DE0501762 and owned by Fotona d.o.o. The device was registered on June 20, 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.

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CLASS C
DE0501762
Fotona SP Spectro Laser System
HSA Registration Number: DE0501762
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Product Description

The Spectro laser system family is intended to be used in dermatology, aesthetic medicine, surgery and gynecology.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0501762
Registration Date
June 20, 2018
Retention Due Date
June 19, 2026
Product Owner
Short Name
Fotona d.o.o
Address
Stegne 7, 1000 Ljubljana, SLOVENIA
Registrant
Address
1004 TOA PAYOH NORTH, #06-10, SINGAPORE 318995
Importer
Address
1004 TOA PAYOH NORTH, #06-10, SINGAPORE 318995
Model Information
Model Name(s)
Foot Switch R08 Ti R11 S-11 PS02 R04 Ti PS01 PS03 S 22 F 22 Adapter GC Assembly G-set speculum, standard Adapter GA Assembly FS-01 SP Spectro M021-4AF/3 R33-T R34-T
Model Identifier(s)
68365 70835 70945 71104 83244 83246 83247 83977 84113 85474 86928 88920 88925 89457 92731 95967 96364