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Rosso

Quanta System Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Quanta System Spa
Italy (IT)

Product code

GEX
21 CFR 878.4810

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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

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