# Optim, LLC

- Location (FDA's records): Sturbridge, MA
- FDA decisions: 6 (2008–2026): 6 510(k) clearances
- Names in FDA's records: Optim, LLC (4); Optim, Inc. (2)
- Product codes: EOB (3), FEH (2), NTN (1)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vision-Sciences, Inc.: 3 (https://510kreport.com/company/vision-sciences)
- Max Endoscopy, Inc.: 2 (https://510kreport.com/company/max-endoscopy)
- Sopro: 1 (https://510kreport.com/company/sopro)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Reichert-Jung, Inc.: 1 (https://510kreport.com/company/reichert-jung)

## Firms that cite its devices most
- Acclarent, Inc.: 1 (https://510kreport.com/company/acclarent)
- Olympus Winter & Ibe GmbH: 1 (https://510kreport.com/company/olympus-winter-ibe)
- Entellus Medical, Inc.: 1 (https://510kreport.com/company/entellus-medical)
- Vision-Sciences, Inc.: 1 (https://510kreport.com/company/vision-sciences)

## Its most-cited devices
- K091829: PLS Portable Light Source (2009), cited by 3
- K080622: Entity Nasoview Led Nasopharyngoscope, Model 006105 (2008), cited by 2
- K200609: ENTity WiFi Video Nasopharyngoscope System (2021), cited by 1
- K122593: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 (2012), cited by 1

## Recent decisions
- K254133: ENTity USB Videoscope System (May 14, 2026)
- K200609: ENTity WiFi Video Nasopharyngoscope System (Jan 13, 2021)
- K130489: Electrode, Flexible Suction Coagulator (Apr 19, 2013)
- K122593: Precision Endoscopic Infrared Coagulator; Model 5100 Single-Use Disposable Maxi-Guide Flexible Lightguide; Model 5100-2 (Sep 13, 2012)
- K091829: PLS Portable Light Source (Jul 28, 2009)
- K080622: Entity Nasoview Led Nasopharyngoscope, Model 006105 (Apr 2, 2008)

Source page: https://510kreport.com/company/optim