Company ยท US
Optim, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 2026 | K254133 | ENTity USB Videoscope System Optim, LLC | EOB |
| Jan 13, 2021 | K200609 | ENTity WiFi Video Nasopharyngoscope System Optim, LLC | EOB |
| Apr 19, 2013 | K130489 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR Optim, LLC | FEH |
| Sep 13, 2012 | K122593 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 Optim, LLC | FEH |
| Jul 28, 2009 | K091829 | PLS PORTABLE LIGHT SOURCE Optim, Inc. | NTN |
| Apr 2, 2008 | K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 Optim, Inc. | EOB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||