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FDA 510(k)

PAPAYA 3D & PAPAYA 3D Plus

K-Number: K220392 · 2022-05-19

ApplicantGenoray Co., Ltd.
Decision Date2022-05-19
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PAPAYA 3D & PAPAYA 3D 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 K220392. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAPAYA 3D & PAPAYA 3D Plus?

PAPAYA 3D & PAPAYA 3D 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 K220392.

When did PAPAYA 3D & PAPAYA 3D Plus receive FDA 510(k) clearance?

PAPAYA 3D & PAPAYA 3D Plus received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220392.

Who is the listed applicant for PAPAYA 3D & PAPAYA 3D 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 3D & PAPAYA 3D Plus?

The FDA product code for PAPAYA 3D & PAPAYA 3D Plus is OAS.

Other records listing Genoray Co., Ltd. as applicant

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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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