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FDA 510(k)

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

K-Number: K240543 · 2024-10-24

ApplicantMedency S.R.L.
Decision Date2024-10-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is a medical device manufactured by Medency S.R.L.. It received FDA 510(k) clearance on 2024-10-24 under approval number K240543. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is a medical device that received FDA 510(k) clearance on 2024-10-24. It is manufactured by Medency S.R.L.. The 510(k) number is K240543.

When was Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) approved by the FDA?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) received FDA 510(k) clearance on 2024-10-24, under approval number K240543.

What company makes Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is manufactured by Medency S.R.L..

What is the FDA product code for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)?

The FDA product code for Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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