Panels › Ophthalmic › Product code OPT · Class 2
Infrared Hematoma Detector
Regulation 882.1935
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OPT
| Company | 510(k)s | Recalls |
|---|---|---|
| Infrascan, Inc. | 5 | 0 |
| Cutera, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2024 | K241389 | Infrascanner Model 2500 (Model 2500) Infrascan, Inc. | OPT |
| Feb 9, 2022 | K211617 | Infrascanner Infrascan, Inc. | OPT |
| Jul 10, 2020 | K200203 | Infrascanner Infrascan, Inc. | OPT |
| Jan 11, 2013 | K120949 | INFRASCANNER Infrascan, Inc. | OPT |
| Dec 13, 2011 | DEN100002 | INFRASCANNER, MODEL 1000 Infrascan, Inc. | OPT |
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