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FDA 510(k)

ORA Method LED Gua Sha (GS-04)

K-Number: K252272 · 2025-10-09

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-10-09
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORA Method LED Gua Sha (GS-04) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-10-09 under approval number K252272. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORA Method LED Gua Sha (GS-04)?

ORA Method LED Gua Sha (GS-04) is a medical device that received FDA 510(k) clearance on 2025-10-09. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252272.

When was ORA Method LED Gua Sha (GS-04) approved by the FDA?

ORA Method LED Gua Sha (GS-04) received FDA 510(k) clearance on 2025-10-09, under approval number K252272.

What company makes ORA Method LED Gua Sha (GS-04)?

ORA Method LED Gua Sha (GS-04) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for ORA Method LED Gua Sha (GS-04)?

The FDA product code for ORA Method LED Gua Sha (GS-04) is OHS.

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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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