Z-3110-2026Class II

Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed...

Name: Z-3110-2026 Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed...
Creator: Lutronic Corporation
Published: 2026-08-06
License: https://open.fda.gov/license/

Lutronic Corporation / initiated 2026-08-06 / Open, Classified / root cause: design

FDA source

Lutronic Corporation began a recall of 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... on 2026-08-06. The reason FDA records is "Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3110-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-06
Posted: 2026-09-04
Recalling firm: Lutronic Corporation
Product: 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
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: Firm began notifying customers on 8/6/26. Customers were instructed to discontinue use of previous parameters and utilize the new revised clinical cryogen parameters. Updated cryogen parameters were provided with the letter. If you have questions or need assistance, please contact Clinical Support at 844-365-5060 or via email at [email protected].
Quantity in commerce: 1065
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and European Union.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3110-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3110-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-04

Product code GEX

K203788Class IIDermaV Laser SystemLutronic Corporation / cleared 2021-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)