Devices / LED masks & light therapy
Solawave
2-in-1 Skincare Mini
FDA cleared · K250532
“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
What it’s cleared for
The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.
From the FDA filing (K250532, page 4) — verbatim — not yet human-reviewed · retrieved 2026-10-19
Who should skip it
- Skip it if you have a light-sensitive condition such as lupus. Source: American Academy of Dermatology: is red light therapy right for your skin?
Safety notes
- Wear eye protection if the directions tell you to, using the eye protection that's recommended. Source: American Academy of Dermatology: is red light therapy right for your skin?
The FDA record
Yes — the FDA record names Solawave 2-in-1 Skincare Mini.
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.
Specifications
- Treatment areas (see source for restrictions)
- face · Source — not yet human-reviewed · retrieved 2026-10-19
- Coded cautions (read full instructions)
- under-18, pregnancy, photosensitive, epilepsy · Source — not yet human-reviewed · retrieved 2026-10-19
Manufacturer-published contraindications; standalone IFU PDF not obtained. Epilepsy is a consult-doctor caution, not an asserted absolute prohibition. - Session minutes (see source for treatment area)
- 12 · Source — not yet human-reviewed · retrieved 2026-10-19
Complete four-area routine; three minutes per area. Variable weekly frequency retained as null. - Cordless
- Yes · Source — not yet human-reviewed · retrieved 2026-10-19
- Warranty (years)
- 1 · Source — not yet human-reviewed · retrieved 2026-10-19
- Return window (days; conditions apply)
- 60 · Source — not yet human-reviewed · retrieved 2026-10-19
Technical details appear only after we’ve checked and cited a source.
Price
USD 119 · Source · retrieved 2026-10-20
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Where to buy
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