DermaV Laser System Model/Catalog Number recall
Lutronic Corporation recalled DermaV Laser System Model/Catalog Number on September 16, 2026 because of utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn. It was sold nationwide.
Why it was recalled
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
What's recalled
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
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Lutronic Corporation, Goyang
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Worldwide distribution - US Nationwide and the countries of Canada and European Union. - Status
- Ongoing
- Recall number
- Z-3110-2026
- Source
- U.S. Food and Drug Administration
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