Device recall
Z-1599-2013: Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The…
FDA device recall · Class II · ConBio, a CynoSure Company
Key facts
| Recall number (Z-number) | Z-1599-2013 |
|---|---|
| Recall event | 65407 |
| Product | Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing… |
| Product code | GEX |
| Recalling firm | ConBio, a CynoSure Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2013 |
| 510(k) numbers | K103118 |
| FEI number | 1000123592 |
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