Class II — Lutronic Corporation
| Recalling firm | Lutronic Corporation |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn. |
| Product | Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatment |
| Quantity | 1065 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and European Union. |
| Initiated | 2026-08-06 |
| Classified | 2026-09-04 |
| Recall number | Z-3110-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Lutronic Corporation (Z-3110-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99601/
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