Lutronic recall: DermaV Laser System
Lutronic Corporation is recalling DermaV Laser System because of a fire hazard – 1065. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on August 6, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | DermaV Laser System |
| Brand | Lutronic |
| Company | Lutronic Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 6, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 1065 |
| Recall ID | 99601 |
Recalled products
- 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
- FDA recall number
- Z-3110-2026
- Codes, lots and dates
- 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
- Quantity
- 1065
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99601
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Goyang, Korea (the Republic of)
Why it was recalled
The problem: a fire hazard.
The reason the FDA lists: “Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the countries of Canada and European Union.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99601, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Lutronic DermaV Laser System recalled?
Yes. Lutronic Corporation recalled it on August 6, 2026; FDA published it September 16, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a fire hazard. The reason given: 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 should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.