Recall Z-3110-2026 ยท GEX Powered Laser Surgical Instrument
Lutronic Corporation
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
| Date | Sep 4, 2026 (initiated Aug 6, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 clinical@cynosurelutronic.com. |
| Quantity | 1065 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and European Union. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203788 | DermaV Laser System Lutronic Corporation, Mar 26, 2021 |