Benchmed logo
Benchmed

EpilME

Neauvia North America

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

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

Neauvia North America
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
View list →

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

1
  • K170179

    LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

    Lumenis, Ltd.

K213261 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K213261 as a predicate