FDAFDA · Food and drugs·Recall number Z-3110-2026
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
Published September 16, 2026 · Recall initiated: August 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Lutronic Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Lot
- Lot Code: Model: DermaV Software Version: 1.06 UDI #: 08800291820200 Serial Numbers: DV025A010, DV025A011, DV025A012, DV025A013, DV025A014, DV025A015 DV025A016, DV025A018, DV025A019, DV025A020, DV025A021, DV025A022, DV025B011, DV025B012, DV025B013, DV025B014, DV025B015, DV025D006, DV025D007, DV025D008, DV025D009, DV025D010, DV025E003, DV025E004, DV025E005, DV025E006, DV025E007, DV025E008, DV025E009, DV025E010, DV025E011, DV025E012, DV025E013, DV025E014, DV025E016, DV025E017, DV025F012, DV025F013, DV025F014, DV025F015, DV025F016, DV025G011, DV025G012, DV025G013, DV025G014, DV025G015, DV025G016, DV025G017, DV025G018, DV025G019, DV025G020, DV025J021, DV025J022, DV025J023, DV025J025, DV025J026, DV025J027, DV025J028, DV025J034, DV025J035, DV025J036, DV025J037, DV025J038, DV025J040, DV025K018, DV025K019, DV025K020, DV025K021, DV025K023, DV025K024, DV025K025, DV025K027, DV025M031, DV025M032, DV025M033, DV025M034, DV026B001, DV026B002, DV026B003, DV026B004, DV026B005, DV026B010, DV026B014, DV026B015, DV026B016, DV026B017, DV026B018, DV026C006, DV026C007, DV026C008, DV026C009, DV026C010, DV025M035
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea (the Republic of)
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.