Cleared Special

K230754 - L12 LED Light Source with AIM

K230754 is an FDA 510(k) clearance for L12 LED Light Source with AIM, manufactured by Stryker. The device is a Class 2 General & Plastic Surgery device with product code OWN cleared through the Special 510(k) pathway after a 25-day FDA review.

K230754 · Stryker · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
25d
Days
Class 2
Risk

K230754 is an FDA 510(k) clearance for the L12 LED Light Source with AIM. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on April 11, 2023 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K230754

510(k) Number K230754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

OWN Device Classification - Class 2, Special Controls

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OWN Confocal Optical Imaging

All 62
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K230754.
1788 4K Camera System with Advanced Imaging Modality
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K230407 · Guangdong Optomedic Technologies, Inc. · Jul 2023
SmartSurgN Visualization System
K213943 · Smartsurgn Incorporated · Nov 2022
VS3-Iridium System (VS3-IR)
K223020 · Visionsense, Ltd. · Oct 2022
780 nm L11 LED Light Source with AIM
K221611 · Stryker · Jun 2022
K230754 · L12 LED Light Source with AIM
Download PDF FDA Summary Stryker