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Bistos Co., Ltd. · Model BT-410F · UDI-DI 08800012341014
6
510(k) clearances
10
Adverse events
1
Recalls
159
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
| Date | Firm | Reason |
|---|---|---|
| 2023-03-20 | DermLite LLC | Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. |
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