Manufacturer
Quanta System SpaRosso
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K211228
- Device name
- Rosso
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-04-23
- Decision date
- 2022-02-02
- Submission type
- Traditional
- Technology type
- Ruby(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
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-III.
Intended 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.
Summary parsed at:2026-06-01 05:38:09 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
1 submission cite K211228 as a predicate