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Open, Classified

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

FDA Recall Z-3110-2026 · Posted 2026-09-04

Recalling FirmLutronic Corporation
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2026-08-06
Product Quantity1065

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.

Firm 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 [email protected].

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada and European Union.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203788DermaV Laser SystemLutronic Corporation · 2021-03-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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