LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
FDA 510(k) clearance K241857 · decided 2024-10-11
Clearance details
- K-number
- K241857
- Device name
- LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
- Applicant
- Dongguan Boyuan Intelligent Technology Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2024-06-27
- Decision date
- 2024-10-11
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dongguan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.