DeviceClearance

Epildream HP 4000 MED— 510(k) K222352

Substantially Equivalent

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

FDA 510(k) clearance K222352 for Epildream HP 4000 MED, Substantially Equivalent on 2023-04-27. Applicant: D.E.A Project S.R.1.. Device class: 2.

Clearance details

Applicant
D.E.A Project S.R.1.
Product code
Code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mapello, IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code GEX

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.