Cleared Traditional

K233076 - Laser Speckle Imaging System (RFLSI CZW)

K233076 is an FDA 510(k) clearance for Laser Speckle Imaging System (RFLSI CZW), manufactured by Rwd Life Science Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code DPT cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K233076 · Rwd Life Science Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
245d
Days
Class 2
Risk

K233076 is an FDA 510(k) clearance for the Laser Speckle Imaging System (RFLSI CZW). Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Rwd Life Science Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 28, 2024 after a review of 245 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2120 - 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 Rwd Life Science Co., Ltd. devices

FDA 510(k) Submission Details - K233076

510(k) Number K233076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date May 28, 2024
Days to Decision 245 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
130d slower than avg
Panel avg: 115d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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.
Eleanor 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.

Regulatory Peers - DPT Probe, Blood-flow, Extravascular

All 14
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K233076.
BIO-PROBE DISPOSABLE INSERT WITH
K132730 · Medtronic, Inc. · May 2014
BIO-PROBE TRANSDUCER (ADULT)
K133903 · Medtronic, Inc. · Apr 2014
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K012747 · Medtronic Perfusion Systems · Sep 2001
TRANSTAR PRESSURE TRANSDUCER
K942377 · Medex, Inc. · Aug 1994
TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
K912404 · Hewlett-Packard Co. · Nov 1991
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K905728 · Hewlett-Packard Co. · Mar 1991