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Fotona SkyPulse - HSA Registration DE0510385

Access comprehensive regulatory information for Fotona SkyPulse in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510385 and owned by Fotona d.o.o. The device was registered on February 25, 2025.

This page provides complete registration details including product owner information, registrant details, 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
DE0510385
Fotona SkyPulse
HSA Registration Number: DE0510385
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Product Description

The device and its accessories are intended to be used in dentistry, dermatology, ENT, surgery and pain management.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0510385
Registration Date
February 25, 2025
Retention Due Date
February 24, 2026
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
Model Information
Model Name(s)
Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip FIBER DELIVERY SPL FIBER DELIVERY SPL FIBER DELIVERY SPL Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Handpiece Handpiece Handpiece Handpiece Handpiece SkyPulse SkyPulse Handpiece Handpiece Handpiece Handpiece Handpiece Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip Fiber tip LA Adapter Fiber tip Fiber tip SkyPulse module SkyPulse module SkyPulse module SkyPulse module SkyPulse module SkyPulse module SkyPulse module SkyPulse module SkyPulse module SkyPulse module
Model Identifier(s)
Conical Sapphire 600/10 Conical Sapphire 600/10 Conical Sapphire 600/12 Conical Sapphire 600/16 Conical Sapphire 600/8, Conical Sapphire 800/12 Conical Sapphire 800/8 Cylindrical Sapphire 1000/4 Cylindrical Sapphire 1000/8 Cylindrical Sapphire 1000/12 Cylindrical Sapphire 1000/4 Cylindrical Sapphire 1000/8 Cylindrical Sapphire 1300/12 Cylindrical Sapphire 1300/8 Fiber Optic 320 µm Fiber Optic 400 µm Fiber Optic 940 µm Flat Sweeps 300/20 Flat Sweeps 300/9 Flat Sweeps 400/14 Flat Sweeps 400/9 Flat Chiseled 500/12 Flat Sweeps 300/20 Flat Sweeps 300/9 Flat Sweeps 400/14 Flat Sweeps 400/9 Flat Varian 500/14 Flat Varian 500/9 Flat Varian 600/14 Flat Varian 600/9 GENOVA (102631) HC02-N (90669) HC14-N (90668) HC14-NE (103740) HC14-NS (95734) M321-A M321-B MarcCo L (104560) MarcCo M (104283) MarcCo S (104563) R17 (90039) R21-C3 (90011) Radial Sweeps 400/9 Radial Sweeps 400/14 Radial Sweeps 400/9 Radial Sweeps 600/14 Radial, Sweeps 600/9 Radial, Sweeps 400/14 Radial, Sweeps 600/14 Radial, Sweeps 600/9 SmoothTouch LA Adapter Thin Chisel 150/12 Thin Chisel 150/12 XD-10 XD-10/19 XD-67/10 XD-67/80/10F XS-A XS-AF XS-B XS-BF XS-C XS-CF