This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


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DEVICE DETAILS

NAME OF DEVICEXP SERIES
ESTABLISHMENT NAMEVENUSYS MEDICAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC8237523616
BRAND NAMEFOTONA
MEDICAL DEVICE CATEGORYMD 1202 - Imaging devices utilising non-ionizing radiation
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONTHIS DEVICE IS A MEDICAL SURGICAL LASER OR AESTHETIC LASER CONSIST OF A WAVELENGTH 1064NM, A LONG-PULSED ND:YAG LASER WHICH IS MEANT FOR APPLICATIONS IN DERMATOLOGY AND GYNECOLOGY.
DEVICE INTENDED PURPOSETHIS MEDICAL DEVICE IS USED IN DERMATOLOGY AND GYNECOLOGY TREATMENT SUCH AS VASCULAR LESIONS AND VAGINAL TIGHTENING.
VALIDITY DATE OF REGISTRATION14/05/2021 - 13/05/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1FOTONA XP DYNAMIS85992 & 92730 (Touch Screen)
2FOTONA XP SPECTRO87005 & 92732 (Touch Screen)
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