DEVICE DETAILS
| NAME OF DEVICE | PICOWAY LASER SYSTEM |
|---|---|
| ESTABLISHMENT NAME | BEAUMEDIC AESTHETIC (M) SDN.BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC5327823-144772 |
| BRAND NAME | CANDELA |
| MEDICAL DEVICE CATEGORY | MD 1402 - Devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The PicoWay Laser System is a solid‐state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, 730 nm (new) or 785 nm at extremely short duration in the range of 240‐500 ps. The laser system contains one 755 nm (Alexandrite) laser head which is used to ‘pump’ (create) the 1064 nm picosecond wavelength. The 1064 nm wavelength can be frequency‐doubled to 532 nm as desired. The outputs of the two lasers are designed to be co‐linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. The current 785 nm and new 730 nm wavelength contain a Ti:Sapphire laser rod that is pumped with the 532 nm energy. All these energies are delivered through an articulated arm and corresponding handpiece. |
| DEVICE INTENDED PURPOSE | The PicoWay laser system is indicated for the following at the specified wavelength: ● 532 nm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange. ● 730 nm: Removal of tattoos for Fitzpatrick Skin Types I-IV to treat the following tattoo colors: green and blue. ● 785 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue. ● 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV. The Resolve handpieces (532 mn HE, 532 rm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV. The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented lesions removal for Fitzpatrick Skin Types II-V. The PicoWay laser system is indicated for the following at the specified wavelengths: 532 nm: ● Treatment of Melasma for Fitzpatrick Skin Types I-IV. ● Treatment of caf6 au lait macules (CALMs) for Fitzpatrick Skin Types I-IV. ● Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 730 nm: ● Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 1064 nm: ● Treatment of Melasma for Fitzpatrick Skin Types I-IV. ● Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV. |
| VALIDITY DATE OF REGISTRATION | 16/08/2023 - 15/08/2028 |