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FDA 510(k)

PAPAYA & PAPAYA Plus

K-Number: K220423 · 2022-05-19

ApplicantGenoray Co., Ltd.
Decision Date2022-05-19
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PAPAYA & PAPAYA Plus is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K220423. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAPAYA & PAPAYA Plus?

PAPAYA & PAPAYA Plus is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K220423.

When did PAPAYA & PAPAYA Plus receive FDA 510(k) clearance?

PAPAYA & PAPAYA Plus received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220423.

Who is the listed applicant for PAPAYA & PAPAYA Plus?

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

What is the FDA product code for PAPAYA & PAPAYA Plus?

The FDA product code for PAPAYA & PAPAYA Plus is MUH.

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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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