NTN
9 FDA 510(k) clearances · Product code
83 daysmedian time to decision
315 days90th percentile
9clearances measured
FDA profile
- Official device name
- Led Light Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
- Adverse events (MAUDE)
- 2021: 47 · 2022: 47 · 2023: 26 · 2024: 32 · 2025: 42 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ARTEMIS LIGHT ENGINE (K141164) | Quest Medical Imaging | 2015-03-16 |
| ENDOLED (K133311) | Olympus Winter & Ibe GmbH | 2014-07-30 |
| CLL- V1 LIGHT SOURCE (K130819) | Olympus Winter & Ibe GmbH | 2013-06-19 |
| VIDEO SYSTEM CENTER (K122831) | Olympus Medical Systems Corp. | 2012-12-14 |
| LUCEA LED SURGICAL LIGHT SYSTEM (K113679) | Maquet S.A.S. | 2012-01-12 |
| SOPRO 281 (K103813) | Sopro | 2011-03-22 |
| LO-50 LED LIGHT SOURCE (K102167) | Fiberoptics Technology, Inc. | 2010-08-17 |
| PLS PORTABLE LIGHT SOURCE (K091829) | Optim, Inc. | 2009-07-28 |
| FSC 2 (K090601) | Schoelly Imaging, Inc. | 2009-05-11 |
Track NTN automatically
Every clearance here is in the API, with alerts when new ones post.