Harpar Grace International

Shani Darden LED light therapy mask

Name: Harpar Grace International Shani Darden LED light therapy mask
Brand: Harpar Grace International

LED light therapy (blue / red) for acne · Full-face mask

Regulatory status

FDA 510(k) cleared

510(k) cleared · Mar 2022 · code OLP

Evidence it works

Mixed/moderate

for the claimed effect — see below

Cleared ≠ proven. An FDA 510(k) clearance means the device may be legally marketed for that use — it is not, on its own, evidence that it works for you. How we grade evidence → Compare with another device →

What it claims

Treats mild to moderate acne
Reduces acne-related redness

Manufacturer / marketing claims — not verified by SkinCarisma.

What the evidence says

Blue (often with red) light for mild-to-moderate acne has reasonable clinical support, but effect sizes vary between studies and benefits usually require repeated sessions. It is not a substitute for prescription treatment in moderate-to-severe acne.

Specifications

Technology: LED light therapy (blue / red) for acne
Wavelengths: Not disclosed by manufacturer
Power / irradiance: Not disclosed
Treatment area: Full-face mask
FDA product code: OLP
510(k) number: K214103
Cleared: 22 Mar 2022

Using this with your skincare

How this device plays with the actives in your routine.

Watch out for

Be cautious layering strong actives (retinoids, AHAs/BHAs, benzoyl peroxide) right before a session if your skin is sensitive — they can heighten irritation.
Photosensitizing medication (isotretinoin, some antibiotics) is a reason to check with a clinician first.

Get the most from it

Use on clean, dry, bare skin — opaque products (especially sunscreen or makeup) block the light.
Apply your serums and moisturizer after the session; never skip morning sunscreen.

General guidance — patch-test new combinations and follow your device's manual.

Safety & who should be careful

Photosensitizing medication (e.g. isotretinoin, some antibiotics, St John's Wort)
History of photosensitive epilepsy or seizures triggered by light
Active skin cancer or undiagnosed lesions in the treatment area
Pregnancy — limited safety data; check with a clinician first
Always use the supplied eye protection; never stare directly into the LEDs

General guidance for this device class — always follow your device's manual and check with a clinician.

Sources

FDA 510(k) K214103 — Harpar Grace International · fetched 2026-06-13

This page is information, not medical advice. Device data comes from the FDA openFDA database and manufacturer filings; SkinCarisma does not independently test devices. For your situation, consult a dermatologist. See our methodology.