Cleared Special

780 nm L11 LED Light Source with AIM

K221611 · Stryker · General & Plastic Surgery
Jun 2022
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K221611 is an FDA 510(k) clearance for the 780 nm L11 LED Light Source with AIM, a Confocal Optical Imaging (Class II — Special Controls, product code OWN), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on June 29, 2022, 26 days after receiving the submission on June 3, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K221611 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2022
Decision Date June 29, 2022
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OWN — Confocal Optical Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.

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