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Bistos Co., Ltd. · Model BT-410A · UDI-DI 00887529000342

HPP
0
510(k) clearances
12
Adverse events
1
Recalls
71
Facilities

Description

This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injured part. This unit doesn't intend to contact directly to the patient's body and can be used for all medical field except ophthalmology.

Recalls

DateFirmReason
2014-06-11Integra LifeSciences Corp.LED battery chargers may prematurely fail and will not charge the LED battery as intended

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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.