# K160227: ACCENTO  /  HWA Dual/Single laser

- Pathway: 510(k) (Traditional)
- Applicant: Bison Medical Co, Ltd.
- Decided: Apr 22, 2016 after 84 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: 11 generations back to K910422 (1992). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130199: Clarity LPC Laser System, Lutronic Corporation (2013) Summary page 5.

## Indications for use
The ACCENTO single laser system is indicated for the following: 755 nm Long pulsed Alexandrite laser Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias) Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime. The ACCENTO combined laser system is indicated for the following: 755 nm Long pulsed Alexandrite laser Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as portofwine stains, hemangiomas, telangiectasias) 1064nm Long pulsed Nd:YAG laser the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle. Permanent hair reduction is defined as the long ferm, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K160227
Methodology: https://510kreport.com/methodology