# K254199: PicoreMax (PicoreMax)

- Pathway: 510(k) (Traditional)
- Applicant: BLUECORE COMPANY Co., Ltd.
- Decided: Sep 24, 2026 after 269 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). 308 ancestors in all.
No later device cites it as a predicate yet.
0 of 309 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240983: Discovery Pico; Discovery Pico Plus; Discovery Pico Derm, Quanta System Spa (2025) Summary page 5.
- K160488: Cutera enlighten III Laser System, Cutera, Inc. (2016) Summary page 5.
- K133254: Revlite Q-Switched ND:Yag Laser System, Cynosure, Inc. (2014) Summary page 5.

## Indications for use
The PicoreMax is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology and general plastic surgery as follows. 532 nm Indicated for the removal of tattoos for Fitzpatrick skin types I – III to treat the following tattoo colors : red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I – IV. (nominal delivered energy of 585 nm and 650 nm with the Optional Dye Laser Handpiece) Tattoo removal (light ink: red, sky blue, green) Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis Skin Resurfacing for Acne Scars and Wrinkles Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength) 1064 nm Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I – VI) to treat the following tattoo colors : black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Focus (Fractional) handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I – IV. Focus (Fractional) handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II – V.

Source page: https://510kreport.com/device/K254199
Methodology: https://510kreport.com/methodology