MAUDE manufacturer profile
SOLTA MEDICAL, INC. · ONG
MAUDE profile for Powered Laser Surgical Instrument With Microbeam\Fractional Output
Key facts
| Manufacturer | SOLTA MEDICAL, INC. |
|---|---|
| Manufacturer group | SOLTA MEDICAL, INC. |
| Product code | ONG |
| Product code name | Powered Laser Surgical Instrument With Microbeam\Fractional Output |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Burn(s), Insufficient Information, Erythema, Skin Discoloration, Partial thickness (Second Degree) Burn, Unspecified Infection, Blister Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1