FDA 510(k)

HandPICO Fractional Laser Handpiece Tip

Numéro K : K242534 · 2024-12-20

Date de décision2024-12-20

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

HandPICO Fractional Laser Handpiece Tip is the device name listed in this FDA 510(k) record. The listed applicant is Vydence Medical. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K242534. 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.

Questions fréquentes

What is the HandPICO Fractional Laser Handpiece Tip?

HandPICO Fractional Laser Handpiece Tip is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Vydence Medical. The 510(k) number is K242534.

When did HandPICO Fractional Laser Handpiece Tip receive FDA 510(k) clearance?

HandPICO Fractional Laser Handpiece Tip received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242534.

Who is the listed applicant for HandPICO Fractional Laser Handpiece Tip?

The FDA 510(k) record lists Vydence Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HandPICO Fractional Laser Handpiece Tip?

The FDA product code for HandPICO Fractional Laser Handpiece Tip is GEX. This falls under the Gastroenterology category.

Essais cliniques associés

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Source officielle

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