Reported Sep 16, 2026 · Ongoing
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy…
Lutronic Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lutronic Corporation · 219 Sowon-Ro; Deogyang · Goyang
Is this the product you have?
- Product NameDermaV
- Laser System Model/Catalog NumberDermaV 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
- Lot codes and dates
- Lot CodeModel:
- DermaV Software Version1.06 UDI #: 08800291820200
- Serial Numbers
92 of 92 codes
DV025A010DV025A011DV025A012DV025A013DV025A014DV025A015 DV025A016DV025A018DV025A019DV025A020DV025A021DV025A022DV025B011DV025B012DV025B013DV025B014DV025B015DV025D006DV025D007DV025D008DV025D009DV025D010DV025E003DV025E004DV025E005DV025E006DV025E007DV025E008DV025E009DV025E010DV025E011DV025E012DV025E013DV025E014DV025E016DV025E017DV025F012DV025F013DV025F014DV025F015DV025F016DV025G011DV025G012DV025G013DV025G014DV025G015DV025G016DV025G017DV025G018DV025G019DV025G020DV025J021DV025J022DV025J023DV025J025DV025J026DV025J027DV025J028DV025J034DV025J035DV025J036
- Amount recalled
- 1065
Where 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.
This product could cause temporary or reversible health problems — stop using it.
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