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Premio 40 - Light

SEDATELEC · Model PREMIO 40 · UDI-DI 03760262493381

KYT
6
510(k) clearances
10
Adverse events
1
Recalls
160
Facilities

Description

The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency.

Recalls

DateFirmReason
2023-03-20DermLite LLCIncorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

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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.