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FDA 510(k)

Regenalase Laser System

K-Number: K233344 · 2024-05-28

ApplicantIpg Medical
Decision Date2024-05-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Regenalase Laser System is a medical device manufactured by Ipg Medical. It received FDA 510(k) clearance on 2024-05-28 under approval number K233344. 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 Regenalase Laser System?

Regenalase Laser System is a medical device that received FDA 510(k) clearance on 2024-05-28. It is manufactured by Ipg Medical. The 510(k) number is K233344.

When was Regenalase Laser System approved by the FDA?

Regenalase Laser System received FDA 510(k) clearance on 2024-05-28, under approval number K233344.

What company makes Regenalase Laser System?

Regenalase Laser System is manufactured by Ipg Medical.

What is the FDA product code for Regenalase Laser System?

The FDA product code for Regenalase Laser System 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

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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