Food, drugs, devices › Lutronic Corporation
Device recall: Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at
Lutronic Corporation (Goyang) initiated this device recall on 6 Aug 2026; FDA lists 1 product record under event 99601, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Lutronic Corporation has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Lutronic Corporation, Goyang, Korea (the Republic of).
Reason for recall
"Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn."
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada and European Union."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 1065 | Class II | Ongoing | 16 Sep 2026 |
Context
Other enforcement events for Lutronic Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jan 2026 | CLARITY II Laser System; Model No. 1110200210. | Device | Class II | 1 |
| 4 Sep 2025 | XERF EFFECTOR 60. Electrosurgical unit. | Device | Class II | 1 |
All 3 events for Lutronic Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada and European Union."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.