Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)— 510(k) K240543

Substantially Equivalent

Medency S.R.L.

FDA 510(k) clearance K240543 for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia), Substantially Equivalent on 2024-10-24. Applicant: Medency S.R.L.. Device class: 2.

Clearance details

Applicant
Medency S.R.L.
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
Vicenza, IT
Download summary PDFView on FDA.gov ↗

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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.