Cleared Traditional

Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);

K243711 · Wuxi Hisky Medical Technologies Co., Ltd. · General & Plastic Surgery

Jul 2025

Decision

234d

Days

Class 2

Risk

About This 510(k) Submission

K243711 is an FDA 510(k) clearance for the Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);, a Confocal Optical Imaging (Class II — Special Controls, product code OWN), submitted by Wuxi Hisky Medical Technologies Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on July 24, 2025, 234 days after receiving the submission on December 2, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K243711 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2024
Decision Date	July 24, 2025
Days to Decision	234 days
Submission Type	Traditional
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.