Recall Z-3110-2026— Lutronic Corporation
Class II · Ongoing
Class II FDA medical device recall by Lutronic Corporation, initiated 2026-08-06. It names one FDA 510(k) clearance: K203788. 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: Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn..
- Recalling firm
- Lutronic Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-06
- Firm location
- Goyang, Korea (the Republic of)
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.