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FDA 510(k)

780 nm L11 LED Light Source with AIM

K-Number: K221611 · 2022-06-29

ApplicantStryker
Decision Date2022-06-29
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

780 nm L11 LED Light Source with AIM is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2022-06-29 under approval number K221611. 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 780 nm L11 LED Light Source with AIM?

780 nm L11 LED Light Source with AIM is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Stryker. The 510(k) number is K221611.

When was 780 nm L11 LED Light Source with AIM approved by the FDA?

780 nm L11 LED Light Source with AIM received FDA 510(k) clearance on 2022-06-29, under approval number K221611.

What company makes 780 nm L11 LED Light Source with AIM?

780 nm L11 LED Light Source with AIM is manufactured by Stryker.

What is the FDA product code for 780 nm L11 LED Light Source with AIM?

The FDA product code for 780 nm L11 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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