Epildream HP 4000 MED

D.E.A Project S.R.1.

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

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K222352
Device name
Epildream HP 4000 MED
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-08-04
Decision date
2023-04-27
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

EPILDREAM HP 4000 MED is indicated for: use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. 760 nm wavelength laser is indicated for: Hair removal, permanent hair reduction. 808 nm wavelength laser is indicated for: Hair removal, permanent hair reduction. 1060 nm wavelength laser is indicated for: • Treatment of pseudofolliculitis barbae (PFB) • Hair removal, permanent hair reduction. *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. Use on all skin types (Fitzpatrick I-VI), including tanned skin. The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.

Intended Use

EPILDREAM HP 4000 MED is indicated for: use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. 760 nm wavelength laser is indicated for: Hair removal, permanent hair reduction. 808 nm wavelength laser is indicated for: Hair removal, permanent hair reduction. 1060 nm wavelength laser is indicated for: Treatment of pseudofolliculitis barbae (PFB), Hair removal, permanent hair reduction. Use on all skin types (Fitzpatrick I-VI), including tanned skin. The handpiece which uses three wavelengths simultaneously is indicated for use in dermatology procedures requiring coagulation, and for the removal of benign vascular and vascular dependent lesions.

Summary parsed at:2026-06-01 05:31:54 UTC

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