Manufacturer
D.E.A Project S.R.1.Epildream HP 4000 MED
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K222352
- Device name
- Epildream HP 4000 MED
- Company
- D.E.A Project S.R.1.
- 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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