Use cautionMedical device recall · FDA · Published August 6, 2026
Lutronic DermaV Laser System Recall: Risk of Patient Burn During Treatment
Lutronic recalls DermaV Medical laser devices with specific serial numbers due to potential patient burns from spark/loud noise during high-fluence treatments at 1064nm wavelength.
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
✎ GovInfoNow plain-language explainer
Lutronic is recalling DermaV laser systems with certain serial numbers because using higher fluences at 1064nm wavelength with current cryogen settings may cause sparks and loud noises that could lead to patient burns. This affects medical devices used for skin treatments. Read more at govinfonow.com/recall/1009697-lutronic-dermav-laser-system-recall-risk-of-patient-burn-during.
“Lutronic DermaV Laser System Recall: Risk of Patient Burn During Treatment.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/1009697-lutronic-dermav-laser-system-recall-risk-of-patient-burn-during. Based on FDA recall #Z-3110-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3110-2026%22&limit=1).
The FDA announced on Aug. 6, 2026, that Lutronic Corporation is recalling the DermaV Medical laser system due to a potential patient burn hazard. The device may produce sparks or loud noises during treatment when utilizing higher fluences at 1064nm wavelength with current cryogen parameters.
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark or loud noise during treatment, potentially resulting in patient burn. The FDA record does not report specific incidents or injuries associated with this recall.
Context
GovInfoNow's records show Lutronic Corporation has two other recalls on record since Sept. 4, 2025. On Jan. 27, 2026, the company recalled the CLARITY II Laser System due to reports of devices sparking or popping and potentially burning patients. Other recent recalls of similar products include Diowave Laser System Recall: Software Update Needed for Safety (Jan. 9, 2026), Repligen Maverick Measurement Module Spectrometer Recall: Laser Safety Risk (Dec. 10, 2025), and Olympus SOLTIVE Laser System Recall: Potential 24V Power Supply Defect (Feb. 27, 2026).
How to tell if you have this one
Check for serial numbers starting with DV025 or DV026 (e.g., DV025A010, DV025B011) on the device label. The system may have software version 1.06 and lot code 08800291820200.
Brand
Lutronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Serial Number
Look for serial numbers starting with DV025 or DV026 on the device label.
Stop Using if Affected
If you have a recalled device, stop using it immediately to prevent potential burns.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada and European Union.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3110-2026 (August 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3110-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.