Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energ
Summary
The FDA issued a Class II for Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser by Lutronic Corporation. Reason: Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resultin.
Details
Source
Device Recall
External ID
Z-3110-2026
Action Date
2026-09-16
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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 Affected: 1065
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-06
Company
Goyang
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Lutronic Corporation has 7 FDA actions in our database, including 3 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Lutronic Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lutronic Corporation have FDA actions?
Lutronic Corporation has 7 FDA actions in our database, including 3 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3110-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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