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FDA 510(k)

HIGHERDOSE Red Light Hat (HG-120K)

K-Number: K242363 · 2024-11-20

Decision Date2024-11-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HIGHERDOSE Red Light Hat (HG-120K) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K242363. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGHERDOSE Red Light Hat (HG-120K)?

HIGHERDOSE Red Light Hat (HG-120K) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K242363.

When did HIGHERDOSE Red Light Hat (HG-120K) receive FDA 510(k) clearance?

HIGHERDOSE Red Light Hat (HG-120K) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K242363.

Who is the listed applicant for HIGHERDOSE Red Light Hat (HG-120K)?

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

What is the FDA product code for HIGHERDOSE Red Light Hat (HG-120K)?

The FDA product code for HIGHERDOSE Red Light Hat (HG-120K) is OAP.

Other records listing Shenzhen Kaiyan Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 24 devices →

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.