# K091829: PLS Portable Light Source

- Pathway: 510(k) (Abbreviated)
- Applicant: Optim, Inc.
- Decided: Jul 28, 2009 after 39 days
- Product code: NTN (Led Light Source)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921244 (1992). 20 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080622: Entity Nasoview Led Nasopharyngoscope, Model 006105, Optim, Inc. (2008) Summary page 1.
- K072912: Sopro 225 Dual Halogen Light Source, Sopro (2007) Summary page 1.

## Most influential descendants
- K130503: Pathassist Led Light Fiber (2013), 6 descendants of its own
- K141916: Pathassist Led Light Fiber (2014), 5 descendants of its own
- K152435: PassAssist LED Light Fiber (2015), 2 descendants of its own
- K212774: VenSure LightGuide (2022), 1 descendant of its own
- K230065: VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (2023), 0 descendants of its own

## Indications for use
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.

Source page: https://510kreport.com/device/K091829
Methodology: https://510kreport.com/methodology