# K222352: Epildream HP 4000 MED

- Pathway: 510(k) (Traditional)
- Applicant: D.E.A Project S.R.1.
- Decided: Apr 27, 2023 after 266 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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.

Source page: https://510kreport.com/device/K222352
Methodology: https://510kreport.com/methodology