FDA recall, , Moderate risk
Lutronic DermaV Laser System
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Summary by Recall Canary from the FDA notice
What happened
Lutronic Corporation, located in Goyang, Korea (the Republic of), began a recall of the DermaV Laser System on August 6, 2026, as stated by the FDA. The medical laser device delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece and may be configured with an Intelligent Cooling Device.
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn. The recall was added to the FDA's Enforcement Report and classified on September 4, 2026, with distribution worldwide, including the US Nationwide, Canada, and the European Union.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
DermaV Laser System
- UDI-DI
- 08800291820200
- Lot code
- 1.06
- 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
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Company
- Lutronic CorporationGoyang, Korea (the Republic of)
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99601
- Recall number
- Z-3110-2026
All recalls from Lutronic Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
