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.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICEQX MAX
ESTABLISHMENT NAMEVENUSYS MEDICAL SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC8425037716
BRAND NAMEFOTONA
MEDICAL DEVICE CATEGORYMD 1402 - Devices utilising non-ionizing radiation
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONTHE FOTONA QX MAX LASER SYSTEMS INCORPORATE THE FOLLOWING LASER SOURCES: -Q-SWITCHED ND:YAG LASER, WITH A WAVELENGTH OF 1064 NM -ACCELERA (ACC) PULSE ND:YAG, WITH A WAVELENGTH OF 1064 NM -FREQUENCY-DOUBLED Q-SWITCHED ND:YAG LASER (OR Q-SWITCHED, KTP), WITH A WAVELENGTH OF 532 NM -BEAM CONVERTER R650, WITH A WAVELENGTH OF 650NM -BEAM CONVERTER R585, WITH A WAVELENGTH OF 585NM -AIMING BEAM DIODE LASER, WITH A WAVELENGTH OF 650 NM
DEVICE INTENDED PURPOSEFOTONA QX MAX LASER SYSTEM AND ITS ACCESSORIES ARE INTENDED FOR TATTOO REMOVAL, TREATMENT OF PIGMENTED AND VASCULAR LESIONS, SURGICAL AND AESTHETIC APPLICATIONS REQUIRING SELECTIVE PHOTOTHERMOLYSIS OF TARGET CHROMOPHORES IN SOFT TISSUE, AND INCISION/EXCISION, ABLATION AND VAPORIZATION OF SOFT TISSUE IN GENERAL DERMATOLOGY.
VALIDITY DATE OF REGISTRATION11/07/2021 - 10/07/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Fotona QX Max laser (Main Body)82398
2Footswitch assembly68356
3Footswitch assembly82665
4HP R2882922
5HP R-HX90025
6HP FS-2093759
7HP FS-20A93760
8HP FS-5093758
9HP R65084367
10HP R58584368
11Safety goggles93479
Back