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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2022-06-29 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K221611.

When did 780 nm L11 LED Light Source with AIM receive FDA 510(k) clearance?

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

Who is the listed applicant for 780 nm L11 LED Light Source with AIM?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: OWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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