Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Discovery Pico, Discovery Pico Plus, Discovery Pico Derm

K-Number: K191842 · 2019-09-17

ApplicantQuanta System Spa
Decision Date2019-09-17
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 2019-09-17 under approval number K191842. 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 2019-09-17. It is manufactured by Quanta System Spa. The 510(k) number is K191842.

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 2019-09-17, under approval number K191842.

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.

Other Devices by Quanta System Spa

K163222Discovery Pico Family K163009Litho K160368EVO platform K160513Quanta System Surgical Laser fibers K1730022940 nm Er:Yag Laser Handpiece K172376Discovery Pico, Discovery Pico Plus

View all 34 devices →

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

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.

↑