FDA 510(k) Clearance
FDA 510(k) Clearance Information
510(k) Number: K251667
Official FDA 510(k) Summary
The LIGHT WELLNESS LED Light Therapy Mask is marketed under a model included in FDA 510(k) clearance K251667, held by Shenzhen Liyoutong Technology Co., Ltd.
Clearance covers the listed models M01, M02, M06, M07, M08, and M09 for their cleared indications. LIGHT WELLNESS is not identified as the 510(k) applicant in the FDA database.
Verified FDA Database Record
| Field | Official FDA Record |
| 510(k) Number | K251667 |
| Applicant | Shenzhen Liyoutong Technology Co., Ltd. |
| Device Name | LED Light Therapy Mask |
| Covered Models | M01, M02, M06, M07, M08, M09 |
| Product Code | OHS |
| Subsequent Product Code | OLP |
| Decision | Substantially Equivalent |
| Decision Date | August 7, 2025 |
Important Clarification
The FDA 510(k) clearance K251667 applies specifically to the LED Light Therapy Mask models listed above, manufactured by Shenzhen Liyoutong Technology Co., Ltd. This clearance should not be interpreted as a general endorsement of all red light therapy devices or all potential effects of red light therapy. The clearance is specific to the covered models and their cleared indications only.
What This Means for You
The LIGHT WELLNESS Crown Mask is marketed as model M09, and the LIGHT WELLNESS Beauty Mask is marketed as model M09, both of which are models listed under FDA 510(k) clearance K251667. This means the FDA has reviewed the device and determined it is substantially equivalent to predicate devices legally marketed in the United States.
The clearance process involves a detailed review of device specifications, performance data, and safety information. It does not constitute FDA approval or endorsement of specific treatment outcomes.
Verify This Information
You can verify this information directly on the FDA database:
This page provides factual information about the FDA regulatory status of the LED Light Therapy Mask. For questions about this clearance, please contact us. Individual results from using any LED light therapy device may vary. This information is not intended as medical advice.