# FDA recall Z-3110-2026

> **Lutronic Corporation** · Class II · device recall initiated 2026-08-06.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-3110-2026
- **Recalling firm:** Lutronic Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-06
- **Report date:** 2026-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Goyang, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3110-2026

## Citation

> MORVS. FDA recall Z-3110-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3110-2026. Source: US FDA. Licensed CC0.

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