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ESPADA Acne-Clearing Blue Light Pen

Foreo AB · Model ESPADA Cobalt Blue · UDI-DI 07350092130271

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

Description

The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

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.