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FDA 510(k)

FLARE Single-Use Surgical Laser Fiber

K-Number: K202702 · 2021-02-26

ApplicantRealton (Suzhou) Medical Technology Co., Ltd.
Decision Date2021-02-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLARE Single-Use Surgical Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K202702. 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 FLARE Single-Use Surgical Laser Fiber?

FLARE Single-Use Surgical Laser Fiber is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202702.

When did FLARE Single-Use Surgical Laser Fiber receive FDA 510(k) clearance?

FLARE Single-Use Surgical Laser Fiber received FDA 510(k) clearance on 2021-02-26, under 510(k) number K202702.

Who is the listed applicant for FLARE Single-Use Surgical Laser Fiber?

The FDA 510(k) record lists Realton (Suzhou) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLARE Single-Use Surgical Laser Fiber?

The FDA product code for FLARE Single-Use Surgical Laser Fiber is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Realton (Suzhou) Medical Technology Co., Ltd. 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.

K202828Surgical Green Laser SystemK202601Single-use Sterile medical laser fiber

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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