Home / Companies / iSMART Developments, Ltd.
3 FDA records filed under this company name, from 2023 to 2026, in light for wrinkles (OHS, 3).
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510(k) cleared
Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.
510(k) cleared
“The décoLITE LED device is an over-the-counter device that is intended for the use in the treatment of wrinkles in the decolletage area.”
Copied from the text of FDA's 510(k) document (PDF, page 4), with line breaks removed.
510(k) cleared
“The LUMA LED light patches are over-the-counter devices intended to emit energy in the visible and near infra-red light spectrum. LUMA Blemish is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. LUMA Revive is an over-the-counter device intended to emit energy in the red and Near infra-red spectrum and is intended for the use in the treatment of facial wrinkles.”
Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.