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LaserME

Neauvia North America

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Neauvia North America
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K230077
Device name
LaserME
Company
Neauvia North America
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-01-10
Decision date
2023-07-17
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Skin resurfacingPigment treatmentVascular treatment
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Intended Use

The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Summary parsed at:2026-06-01 05:32:26 UTC

Predicate devices

1

K230077 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K230077 as a predicate