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FDA 510(k)

OxyLight 2.0

K-Number: K202175 · 2021-12-02

ApplicantRaja Trading Company, Inc.
Decision Date2021-12-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OxyLight 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Raja Trading Company, Inc.. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K202175. 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 OxyLight 2.0?

OxyLight 2.0 is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Raja Trading Company, Inc.. The 510(k) number is K202175.

When did OxyLight 2.0 receive FDA 510(k) clearance?

OxyLight 2.0 received FDA 510(k) clearance on 2021-12-02, under 510(k) number K202175.

Who is the listed applicant for OxyLight 2.0?

The FDA 510(k) record lists Raja Trading Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OxyLight 2.0?

The FDA product code for OxyLight 2.0 is GEX. This falls under the Gastroenterology category.

Other records listing Raja Trading Company, Inc. as applicant

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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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