Cleared Traditional

K231854 - 1788 4K Camera System with Advanced Ima...

Also marketed or referenced as:
L12 LED Light Source with AIM

K231854 is the FDA 510(k) clearance for 1788 4K Camera System with Advanced Ima... by Stryker. It is a Class 2 General & Plastic Surgery device (product code OWN) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K231854 · Stryker · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
89d
Days
Class 2
Risk

K231854 is an FDA 510(k) clearance for the 1788 4K Camera System with Advanced Imaging Modality. 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 September 20, 2023 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker devices

Submission Details

510(k) Number K231854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2023
Decision Date September 20, 2023
Days to Decision 89 days
Submission Type Traditional
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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K231854.
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ActivSight Intraoperative Imaging System
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FloNavi Open Field Fluorescence Imaging System
K230407 · Guangdong Optomedic Technologies, Inc. · Jul 2023
L12 LED Light Source with AIM
K230754 · Stryker · Apr 2023