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FDA 510(k)

Discovery Pico; Discovery Pico Plus; Discovery Pico Derm

K-Number: K240983 · 2025-06-06

ApplicantQuanta System Spa
Decision Date2025-06-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Discovery Pico; Discovery Pico Plus; Discovery Pico Derm is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2025-06-06 under approval number K240983. 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 Discovery Pico; Discovery Pico Plus; Discovery Pico Derm?

Discovery Pico; Discovery Pico Plus; Discovery Pico Derm is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Quanta System Spa. The 510(k) number is K240983.

When was Discovery Pico; Discovery Pico Plus; Discovery Pico Derm approved by the FDA?

Discovery Pico; Discovery Pico Plus; Discovery Pico Derm received FDA 510(k) clearance on 2025-06-06, under approval number K240983.

What company makes Discovery Pico; Discovery Pico Plus; Discovery Pico Derm?

Discovery Pico; Discovery Pico Plus; Discovery Pico Derm is manufactured by Quanta System Spa.

What is the FDA product code for Discovery Pico; Discovery Pico Plus; Discovery Pico Derm?

The FDA product code for Discovery Pico; Discovery Pico Plus; Discovery Pico Derm 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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