# K203491: PicoLO Nd: YAG Picosecond Laser System - Pathway: 510(k) (Special) - Applicant: Laseroptek Co., Ltd. - Decided: Apr 7, 2021 after 131 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: 26 generations back to K943450 (1995). 287 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 289 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K183392: PicoLO Nd:YAG Picosecond Laser System, Laseroptek Co., Ltd. (2019) ## Most influential descendants - K212573: PicoLO Premium (2021), 0 descendants of its own ## Indications for use PicoLO laser system 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 laser system 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 laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types 11-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. Source page: https://510kreport.com/device/K203491 Methodology: https://510kreport.com/methodology