Data / Medical devices / United States / Optim LLC
Optim LLC: FDA-registered device maker in Sturbridge, MA, United States, 3 510(k) clearances
Optim LLC is registered with the FDA (registration 1218141) in Sturbridge, MA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 28, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1218141
- Address
- 64 Technology Park RD., Sturbridge, MA, United States, 01566
- Owner or operator
- OPTIM LLC (1218141)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 4, 2008
- Registered through
- 2026
- Brand names listed
- ENT 3.6FP, ENTity, Portable Light Source, Vidcap Camera Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Television, Endoscopic, Without Audio | FWF | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2009 | K091829 | PLS PORTABLE LIGHT SOURCE | NTN | Substantially Equivalent | Optim, Inc. | accessdata.fda.gov |
| April 2, 2008 | K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | EOB | Substantially Equivalent | Optim, Inc. | accessdata.fda.gov |
| February 10, 1987 | K864821 | AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 | EOB | Substantially Equivalent | Reichert-Jung, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Led Light Source
Updated July 28, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.