RecalledThisWeek Search
Medium risk Drugs & MedicationsClass II

Lutronic Corporation Recall

Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532

Updated August 6, 2026

Lutronic Corporation is recalling Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532. Hazard: Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Is the Lutronic Corporation recalled? Yes. This product was recalled by FDA on August 6, 2026. Details below.

What is recalled

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

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.

Brands affected

Lutronic Corporation
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-3110-2026
Classification
Class II
Recalled
August 6, 2026
Read the official notice

Get free recall alerts

New Drugs & Medications recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Drugs & Medications recalls