Lutronic Corporation — Class II: Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device th
Lutronic Corporation is recalling the DermaV Laser System due to reports of sparks and loud noises during treatment when using higher fluences at the 1064nm wavelength with specific cryogen parameters. This malfunction poses a potential risk of patient burns.
Lutronic Corporation, clinicians utilizing the DermaV Laser System for dermatological treatments, and quality/regulatory personnel managing medical laser safety protocols.
This recall highlights a technical interaction between high-energy laser settings and cryogen cooling systems that compromises patient safety. From a regulatory perspective, this indicates a need for potentially revised treatment parameters or hardware/software modifications to prevent thermal injury. The 'Ongoing' status suggests that field corrections or device updates are likely still in progress.
QA and regulatory teams should identify affected DermaV units and evaluate if current labeling or user manuals sufficiently address the risk of sparking at high fluences. Clinical operations should ensure operators are aware of the risk when using the 1064nm wavelength and cryogen cooling features until a permanent corrective action is implemented.
Class II. 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.. 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. Firm: Lutronic Corporation (Goyang Korea (the Republic of)). Status: Ongoing.
Open in openFDA / FDA.gov