Recall Z-3110-2026
- Recall number
- Z-3110-2026
- Event number
- 99601
- Firm
- Lutronic Corporation
- Firm FEI
- 3004483538
- Product code
- GEX
- Status
- Open, Classified
- Initiated
- 2026-08-06
- Posted
- 2026-09-04
- Root cause
- Device Design
- 510(k) numbers
- K203788, K041011, K082004, K113502, K972368, K073583, K241293, K053604, K014236, K030480, K251094, K081939, K202258, K050824, K173359, K073411, K253251, K252658, K062312, K043251, K022569, K912703, K062822, K012682, K214049, K040055, K854998, K921843, K000503, K071469
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
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.