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FDA 510(k)

Discovery Pico Family

K-Number: K163222 · 2016-12-05

ApplicantQuanta System Spa
Decision Date2016-12-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Discovery Pico Family is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K163222. 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 Family?

Discovery Pico Family is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Quanta System Spa. The 510(k) number is K163222.

When did Discovery Pico Family receive FDA 510(k) clearance?

Discovery Pico Family received FDA 510(k) clearance on 2016-12-05, under 510(k) number K163222.

Who is the listed applicant for Discovery Pico Family?

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

What is the FDA product code for Discovery Pico Family?

The FDA product code for Discovery Pico Family is GEX. This falls under the Gastroenterology category.

Other records listing Quanta System Spa as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermK243588Single Use CO2 Laser Fiber (HAF005001)K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTK242251Litho 60; Litho 100; Litho 150K232236EchoK223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.K261570PICOSURE WORKSTATIONCynosure, LLC

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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