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Therabody

Therabody, Inc. · Model TheraFace Mask Glo · UDI-DI 00840295409672

OLPOHS
10
510(k) clearances
51
Adverse events (1 deaths)
4
Recalls
112
Facilities

Description

TheraFace Mask Glo is the only one of its kind to help relax, restore and rejuvenate your skin. This mask combines504 full-face Red, Blue, and Red + Infrared LED lights

Recalls

DateFirmReason
2017-12-04Accord Media, LLCDistribution of medical devices with unapproved green LED light used to treat hyperpigmentation
2017-12-04Accord Media, LLCDistribution of medical devices with unapproved green LED light used to treat hyperpigmentation
2017-12-04Accord Media, LLCDistribution of medical devices with unapproved green LED light used to treat hyperpigmentation
2017-12-04Accord Media, LLCDistribution of medical devices with unapproved green LED light used to treat hyperpigmentation

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.