Cleared Traditional

K243711 - Confocal Microprobe Imaging System (BrightP980) (FDA 510(k) Clearance)

Also includes:
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)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243711 · Wuxi Hisky Medical Technologies Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
234d
Days
Class 2
Risk

K243711 is an FDA 510(k) clearance for the Confocal Microprobe Imaging System (BrightP980). Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Wuxi Hisky Medical Technologies Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on July 24, 2025 after a review of 234 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Wuxi Hisky Medical Technologies Co., Ltd. devices

Submission Details

510(k) Number K243711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 114d · This submission: 234d
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 Consultant

Pureid Medical Technology Co., Ltd.
Jarvis Wu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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