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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 a medical device manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under approval 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. It is manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The 510(k) number is K202702.

When was FLARE Single-Use Surgical Laser Fiber approved by the FDA?

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

What company makes FLARE Single-Use Surgical Laser Fiber?

FLARE Single-Use Surgical Laser Fiber is manufactured by Realton (Suzhou) Medical Technology Co., Ltd..

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.

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Other Devices by Realton (Suzhou) Medical Technology Co., Ltd.

K202601Single-use Sterile medical laser fiber K202828Surgical Green Laser System

Related Devices (Code: GEX)

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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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