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Lustre
Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model PR5001 · UDI-DI 05060282690318
1
510(k) clearances
51
Adverse events (1 deaths)
4
Recalls
116
Facilities
Description
The LUSTRE 3XPREsS Light Beauty Therapy patches (Model: PR500l) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
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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