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DEVICE DETAILS

NAME OF DEVICESKYPULSE
ESTABLISHMENT NAMEVENUSYS MEDICAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC6239524-179855
BRAND NAMEFOTONA
MEDICAL DEVICE CATEGORYMD 1402 - Devices utilising non-ionizing radiation
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe SkyPulse laser system family consists of two different versions: • SkyPulse M321-A abbreviated as SkyPulse Versa / Endo Pro which has XS-A Er:YAG laser module and offers water spray for cooling the treated area or Endo Plus which can have XS- A or XSC Er:YAG laser module and also offers water spray for cooling the treated area. • SkyPulse M321-B abbreviated as SkyPulse Endo which has XSB Er:YAG laser module and does not offer water spray for cooling the treated area.
DEVICE INTENDED PURPOSEThe device and its accessories are intended to be used in dentistry, aesthetics, dermatology, ENT, surgery and pain management.
VALIDITY DATE OF REGISTRATION17/08/2024 - 16/08/2029

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