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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2013 | Cutera, Inc. Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA
The truSculpt massage device i Terminated |
OPT | K122389 |
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