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Lutronic Corporation FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energClass IIAug 6, 2026Utilizing higher fluences at 1064nm wavelength with current |
| CLARITY II Laser System; Model No. 1110200210.Class IIJan 27, 2026Reports of devices sparking/popping and potentially burning |
| XERF EFFECTOR 60. Electrosurgical unit.Class IISep 4, 2025Manufacturing defects in devices manufactured from 4/1/25 to |