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 a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under approval 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. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K220392.
When was PAPAYA 3D & PAPAYA 3D Plus approved by the FDA?
PAPAYA 3D & PAPAYA 3D Plus received FDA 510(k) clearance on 2022-05-19, under approval number K220392.
What company makes PAPAYA 3D & PAPAYA 3D Plus?
PAPAYA 3D & PAPAYA 3D Plus is manufactured by Genoray Co., Ltd..
What is the FDA product code for PAPAYA 3D & PAPAYA 3D Plus?
The FDA product code for PAPAYA 3D & PAPAYA 3D Plus is OAS.
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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.