Recall Z-3110-2026
Lutronic Corporation · initiated August 6, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / 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
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.
FDA-determined cause: Device Design
Action taken
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 clinical@cynosurelutronic.com.
Details
- Recall number
- Z-3110-2026
- Initiated
- August 6, 2026
- Posted by FDA
- September 4, 2026
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 1065
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and European Union.
- Recalling firm
- Lutronic Corporation