Cleared Special

L12 LED Light Source with AIM

K230754 · Stryker · General & Plastic Surgery
Apr 2023
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K230754 is an FDA 510(k) clearance for the L12 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 April 11, 2023, 25 days after receiving the submission on March 17, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K230754 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2023
Decision Date April 11, 2023
Days to Decision 25 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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