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Sep 16, 2026newest stored source record
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Medical DeviceSep 16, 2026

Lutronic DermaV Laser System recall — FDA Z-3110-2026

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Class IIFDA: OngoingLutronic Corporation
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