Manufacturer
Neauvia North AmericaEpilME
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K213261
- Device name
- EpilME
- Company
- Neauvia North America
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-09-30
- Decision date
- 2022-06-02
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
Laser EpilME with EpilME applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. The EpilMe with EpilME Applicator is intended for: * Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins * Treatment of pseudofolliculitis barbae (PFB) * Hair removal, permanent hair reduction* * Treatment of benign pigmented lesions * Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Intended Use
Laser EpilME with EpilME applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. The EpilMe with EpilME Applicator is intended for: * Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins * Treatment of pseudofolliculitis barbae (PFB) * Hair removal, permanent hair reduction * Treatment of benign pigmented lesions * Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Summary parsed at:2026-06-01 05:38:46 UTC
Predicate devices
1LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
K213261 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K213261 as a predicate