# K211228: Rosso

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Feb 2, 2022 after 285 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
694 nm nanosecond (QS mode) Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink; Pigmented lesion removal (benign): - Cafe au lait spot - Ephalides, solar lentigo lentigines - Becker Nevus - Ota and Ito Nevus - Nevus spilus - Mongolian spot. 694 nm picosecond (PS mode) Indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types 1-111.

Source page: https://510kreport.com/device/K211228
Methodology: https://510kreport.com/methodology