Optim LLC
Sturbridge, MA, US
OPTIM LLC appears in FDA device records in Sturbridge, MA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Optim LLC between 2008 and 2026. The busiest year on record is 2008, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2021 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254133 | ENTity USB Videoscope System | EOB | Substantially Equivalent | |
| K200609 | ENTity WiFi Video Nasopharyngoscope System | EOB | Substantially Equivalent | |
| K130489 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | FEH | Substantially Equivalent | |
| K122593 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | FEH | Substantially Equivalent | |
| K091829 | PLS PORTABLE LIGHT SOURCE | NTN | Substantially Equivalent | |
| K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | EOB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1218141 | 1218141 | OPTIM LLC | 64 TECHNOLOGY PARK RD., Sturbridge, MA 01566 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain