HIGHERDOSE Red Light Hat (HG-120K)— 510(k) K242363
Substantially EquivalentShenzhen Kaiyan Medical Equipment Co., Ltd.
FDA 510(k) clearance K242363 for HIGHERDOSE Red Light Hat (HG-120K), Substantially Equivalent on 2024-11-20. Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.