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FDA 510(k)

UltraClear Laser System (N/A)

K-Number: K233803 · 2024-05-08

ApplicantAcclaro Corporation
Decision Date2024-05-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UltraClear Laser System (N/A) is a medical device manufactured by Acclaro Corporation. It received FDA 510(k) clearance on 2024-05-08 under approval number K233803. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraClear Laser System (N/A)?

UltraClear Laser System (N/A) is a medical device that received FDA 510(k) clearance on 2024-05-08. It is manufactured by Acclaro Corporation. The 510(k) number is K233803.

When was UltraClear Laser System (N/A) approved by the FDA?

UltraClear Laser System (N/A) received FDA 510(k) clearance on 2024-05-08, under approval number K233803.

What company makes UltraClear Laser System (N/A)?

UltraClear Laser System (N/A) is manufactured by Acclaro Corporation.

What is the FDA product code for UltraClear Laser System (N/A)?

The FDA product code for UltraClear Laser System (N/A) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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