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Class IIOngoing

Lutronic Corporation recalls Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser

Recall date · record updated Sep 16, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Lutronic Corporation
Reason
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99601…

Products

  1. 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

    Codes/lots: 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,Quantity: 1065Recall no. Z-3110-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

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Proof: raw official record (JSON) · fetched from FDA API

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