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 a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under approval 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. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K242363.
When was HIGHERDOSE Red Light Hat (HG-120K) approved by the FDA?
HIGHERDOSE Red Light Hat (HG-120K) received FDA 510(k) clearance on 2024-11-20, under approval number K242363.
What company makes HIGHERDOSE Red Light Hat (HG-120K)?
HIGHERDOSE Red Light Hat (HG-120K) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..
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.
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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.