FDA records / LED masks & light therapy
Is Solawave 2-in-1 Skincare Mini FDA cleared?
Yes — the FDA record names Solawave 2-in-1 Skincare Mini.
The model name is matched to the linked record below. Clearance is specific to the device and stated use; it is not a performance ranking.
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. What clearance means
Follow the FDA record.
K250532 · View FDA record
- Device name in the FDA record
- Solawave 2-in-1 Skincare Mini (Model: 61043)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decision date
- 2025-05-22
- Product code
- OHS: Light Based Over The Counter Wrinkle Reduction
- Evidence
- FDA record names this model; retail model variants are not inferred. openFDA source; retrieved 2026-10-19.