FDA-Device2026-09-16Class IIPROCESSING DEFECT
Lutronic DermaV Laser System recalled for patient burn risk at high fluences
What this means
Lutronic's DermaV laser system may produce sparks and loud noise when used at higher energy levels (fluences) at the 1064 nm wavelength with current cooling settings. This spark hazard could result in patient burns during treatment.
- If you operate this device, check your serial number against the FDA list to confirm whether your unit is affected.
- Contact Lutronic Corporation for instructions on how to proceed — the company will provide updated settings or firmware to prevent the hazard.
- Do not use affected units at higher fluences on the 1064 nm wavelength until you receive corrective guidance.
The agency's original wording
Hazard
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
Affected count
1065
Manufactured in
219 Sowon-Ro; Deogyang, Goyang, Korea (the Republic of)
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3110-2026Want us to check the next one for you?
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