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Tanda Beauty Canada, Inc · Model Series 14 · UDI-DI 00806248007241
10
510(k) clearances
51
Adverse events (1 deaths)
4
Recalls
117
Facilities
Description
Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne. This is a tester 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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