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NURYSH
UPLEVITY LLC · Model LYFT3 · UDI-DI 00855950007049
1
510(k) clearances
51
Adverse events (1 deaths)
4
Recalls
118
Facilities
Description
A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| 2017-12-04 | Accord Media, LLC | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
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