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FDA 510(k)

Laser Speckle Imaging System (RFLSI CZW)

K-Number: K233076 · 2024-05-28

ApplicantRwd Life Science Co., Ltd.
Decision Date2024-05-28
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Laser Speckle Imaging System (RFLSI CZW) is a medical device manufactured by Rwd Life Science Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under approval number K233076. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laser Speckle Imaging System (RFLSI CZW)?

Laser Speckle Imaging System (RFLSI CZW) is a medical device that received FDA 510(k) clearance on 2024-05-28. It is manufactured by Rwd Life Science Co., Ltd.. The 510(k) number is K233076.

When was Laser Speckle Imaging System (RFLSI CZW) approved by the FDA?

Laser Speckle Imaging System (RFLSI CZW) received FDA 510(k) clearance on 2024-05-28, under approval number K233076.

What company makes Laser Speckle Imaging System (RFLSI CZW)?

Laser Speckle Imaging System (RFLSI CZW) is manufactured by Rwd Life Science Co., Ltd..

What is the FDA product code for Laser Speckle Imaging System (RFLSI CZW)?

The FDA product code for Laser Speckle Imaging System (RFLSI CZW) is DPT.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Related Devices (Code: DPT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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