L12 LED Light Source with AIM— 510(k) K260108
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K260108 for L12 LED Light Source with AIM, Substantially Equivalent on 2026-02-12. Applicant: Stryker Endoscopy. Device class: 2.
Summary
Stryker Endoscopy's L12 LED Light Source with AIM is filed under product code OWN, confocal optical imaging. The record doesn't describe it beyond the name and that code name.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Special 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Stryker Endoscopy filed from San Jose, California. FDA found it substantially equivalent 29 calendar days after receipt (January 14 to February 12, 2026).
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Product code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Recent devices under product code OWN
view allMore clearances from Stryker Endoscopy
view all- K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down
- DEN250040 — SportSuite Vision Software
- K253602 — Precision S 4K Sinuscope
- K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.