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MEDICAL DEVICE RECALLMODERATE
DermaV Laser System
Lutronic recalls DermaV Laser System over burn risk from spark/loud noise at high fluences.
What to do
Stop using the DermaV Laser System and contact Lutronic Corporation for instructions on how to address the issue.
Why it was recalled
Lutronic Corporation is recalling the DermaV Laser System because using higher fluences at the 1064 nm wavelength with current cryogen parameters may result in a spark or loud noise during treatment, potentially causing patient burns.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
DermaV Laser System
- Lot code
- 1.06
- UDI-DI
- 08800291820200
- 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
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-09-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification