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EVRL-OTC
ERCHONIA CORPORATION, LLC · Model EVRL3-OTC · UDI-DI 00858985006360
1
510(k) clearances
51
Adverse events (1 deaths)
4
Recalls
116
Facilities
Description
MEDICAL - Handheld Low Level Laser - OTC - 2 diodes 640nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction 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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