Search Results
Found 1 results
510(k) Data Aggregation
K Number
K222352Device Name
Epildream HP 4000 MED
Manufacturer
Date Cleared
2023-04-27
(266 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
D.E.A Project S.r.1.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EPILDREAM HP 4000 MED is indicated for: use in aesthetic 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.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1