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FDA 510(k)

Surgical Laser fibers

K-Number: K180158 · 2018-02-14

ApplicantQuanta System Spa
Decision Date2018-02-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surgical Laser fibers 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 2018-02-14 under 510(k) number K180158. 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 Surgical Laser fibers?

Surgical Laser fibers is a medical device that received FDA 510(k) clearance on 2018-02-14. The listed applicant is Quanta System Spa. The 510(k) number is K180158.

When did Surgical Laser fibers receive FDA 510(k) clearance?

Surgical Laser fibers received FDA 510(k) clearance on 2018-02-14, under 510(k) number K180158.

Who is the listed applicant for Surgical Laser fibers?

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 Surgical Laser fibers?

The FDA product code for Surgical Laser fibers 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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.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.

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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