# K212573: PicoLO Premium - Pathway: 510(k) (Special) - Applicant: Laseroptek Co., Ltd. - Decided: Dec 8, 2021 after 114 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 27 generations back to K943450 (1995). 288 ancestors in all. No later device cites it as a predicate yet. 0 of 289 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K203491: PicoLO Nd: YAG Picosecond Laser System, Laseroptek Co., Ltd. (2021) Summary page 4. ## Indications for use PicoLO Premium is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064nm The 1064nm wavelength of the PicoLO Premium is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple 532nm The 532nm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-1II to treat the following tattoo colors: red, yellow and orange. The PicoL.O Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. PicoL.O Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. Source page: https://510kreport.com/device/K212573 Methodology: https://510kreport.com/methodology