FDA 510(k)

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

K-Number: K200469 · 2020-09-16

Decision Date2020-09-16

Product CodeOAS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PAPAYA 3D Premium & PAPAYA 3D Premium Plus is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2020-09-16 under approval number K200469. 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 Premium & PAPAYA 3D Premium Plus?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus is a medical device that received FDA 510(k) clearance on 2020-09-16. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K200469.

When was PAPAYA 3D Premium & PAPAYA 3D Premium Plus approved by the FDA?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus received FDA 510(k) clearance on 2020-09-16, under approval number K200469.

What company makes PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

PAPAYA 3D Premium & PAPAYA 3D Premium Plus is manufactured by Genoray Co., Ltd..

What is the FDA product code for PAPAYA 3D Premium & PAPAYA 3D Premium Plus?

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

Other Devices by Genoray Co., Ltd.

K181943OSCAR (OSCAR Prime, OSCAR Classic) K172810PORT-X IV K172180OSCAR 15 K220392PAPAYA 3D & PAPAYA 3D Plus K220423PAPAYA & PAPAYA Plus K211780ZEN-2090 Turbo

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Related Devices (Code: 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.