Cleared Special

K260108 - L12 LED Light Source with AIM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260108 · Stryker Endoscopy · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
29d
Days
Class 2
Risk

K260108 is an FDA 510(k) clearance for the L12 LED Light Source with AIM. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on February 12, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Endoscopy devices

Submission Details

510(k) Number K260108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2026
Decision Date February 12, 2026
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 114d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWN Confocal Optical Imaging

All 60
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K260108.
SmartSurgN Visualization System
K242163 · Smartsurgn, Inc. · Apr 2026
KARL STORZ ICG Imaging System with RUBINA® Lens
K254242 · Karl Storz SE & CO. KG · Feb 2026
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
K251852 · VPIX Medical, Inc. · Feb 2026
IMAGE1 (TC400US)
K253972 · Karl Storz SE & CO. KG · Feb 2026
VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700)
K251336 · Olympus Medical Systems Corp. · Nov 2025
Confocal Microprobe Imaging System (BrightP980)
K243711 · Wuxi Hisky Medical Technologies Co., Ltd. · Jul 2025