Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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 nm HE, 532 nm, 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 I-IV. 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 café 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.
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 II-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 nm HE, 532 nm, 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 I-IV. 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 café 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.
The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, 785 nm, or 730 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 / 532 nm wavelengths. The outputs of the two lasers are optically combined 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 532 nm or 1064 nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064 nm and two for 532 nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532 nm, which delivers a 10 x 10 array of focused and ring spots to the skin. The following handpieces are cleared to be used with PicoWay Laser System: Zoom Handpieces: 532 nm, 1064 nm; Handpieces: 730 nm, 785 nm; Resolve Handpieces: 532 nm, 532 nm HE, 1064 nm; Resolve Fusion Handpieces: 532 nm, 1064 nm.
Summary parsed at:2026-06-01 05:39:57 UTC
