Device recall
Z-1354-2023: thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF…
FDA device recall · Class II · Solta Medical Inc
Key facts
| Recall number (Z-number) | Z-1354-2023 |
|---|---|
| Recall event | 91847 |
| Product | thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; "… |
| Product code | GEI |
| Recalling firm | Solta Medical Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K173759 |
| FEI number | 3004106598 |
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