Device recall
Z-3110-2026: Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser…
FDA device recall · Class II · Lutronic Corporation
Key facts
| Recall number (Z-number) | Z-3110-2026 |
|---|---|
| Recall event | 99601 |
| 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… |
| Product code | GEX |
| Recalling firm | Lutronic Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203788 |
| FEI number | 3004483538 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database