Manufacturer
Neauvia North AmericaLaserME
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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—
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Not ingested
K230077 references 1 predicate/reference device
Cited as predicate
1Medical diode laser systems (CHARISMA, REGAL)
1 submission cite K230077 as a predicate