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HSA · registration DE0510385

Fotona SkyPulse

SingaporeGeneral & Plastic SurgeryClass CFotona d.o.o
Verified
Official record identity
Registration number
DE0510385
Model name
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
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
Registration date
February 25, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
General & Plastic Surgery
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Published parties
Product owner
Fotona d.o.o
Registrant / registration holder
QUALTECH CONSULTING CORPORATION PTE. LTD.
Official description

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

Additional source fields
Product owner address
Stegne 7, 1000 Ljubljana, Slovenia
Registrant address
111 NORTH BRIDGE ROAD, #21-01, PENINSULA PLAZA, Singapore 179098
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.