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FDA 510(k)

L12 LED Light Source with AIM

K-Number: K260108 · 2026-02-12

ApplicantStryker Endoscopy
Decision Date2026-02-12
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

L12 LED Light Source with AIM is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2026-02-12 under approval number K260108. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L12 LED Light Source with AIM?

L12 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Stryker Endoscopy. The 510(k) number is K260108.

When was L12 LED Light Source with AIM approved by the FDA?

L12 LED Light Source with AIM received FDA 510(k) clearance on 2026-02-12, under approval number K260108.

What company makes L12 LED Light Source with AIM?

L12 LED Light Source with AIM is manufactured by Stryker Endoscopy.

What is the FDA product code for L12 LED Light Source with AIM?

The FDA product code for L12 LED Light Source with AIM is OWN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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