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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 the device name listed in this FDA 510(k) record. The listed applicant is Rwd Life Science Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) 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. The listed applicant is Rwd Life Science Co., Ltd.. The 510(k) number is K233076.

When did Laser Speckle Imaging System (RFLSI CZW) receive FDA 510(k) clearance?

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

Who is the listed applicant for Laser Speckle Imaging System (RFLSI CZW)?

The FDA 510(k) record lists Rwd Life Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: DPT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0Spectralmd, Inc.K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imagerMoor Instruments, Ltd.

Official Source

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

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