Warning letter
Curewave Lasers LLC: warning letter of Dec 12, 2019
FDA warning letter 593692 · Office of Medical Device and Radiological Health Operations (Division 3)
Key facts
| Reference number | 593692 |
|---|---|
| Company | Curewave Lasers LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Dec 12, 2019 |
| Posted date | Jan 21, 2020 |
| Issuing office | Office of Medical Device and Radiological Health Operations (Division 3) |
| Product type | Devices |
| CFR sections cited | 1004.1, 1002.10, 1002.13, 1003.20, 1003.21, 1003.30, 1004.2, 1004.6, 1010, 1010.2(c), 1040.11(a)(3), 1003.10(b) and 12 more |
| Inspection city | Dallas |
| Inspection ZIP | 75230 |
| Inspection start date | Aug 22, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: