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FDA 510(k)

VaporMAX LDD; MOJo LDD; MegaJOULE LDD

K-Number: K233157 · 2024-05-03

ApplicantInnovaquartz, LLC
Decision Date2024-05-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VaporMAX LDD; MOJo LDD; MegaJOULE LDD is the device name listed in this FDA 510(k) record. The listed applicant is Innovaquartz, LLC. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K233157. 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 VaporMAX LDD; MOJo LDD; MegaJOULE LDD?

VaporMAX LDD; MOJo LDD; MegaJOULE LDD is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Innovaquartz, LLC. The 510(k) number is K233157.

When did VaporMAX LDD; MOJo LDD; MegaJOULE LDD receive FDA 510(k) clearance?

VaporMAX LDD; MOJo LDD; MegaJOULE LDD received FDA 510(k) clearance on 2024-05-03, under 510(k) number K233157.

Who is the listed applicant for VaporMAX LDD; MOJo LDD; MegaJOULE LDD?

The FDA 510(k) record lists Innovaquartz, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VaporMAX LDD; MOJo LDD; MegaJOULE LDD?

The FDA product code for VaporMAX LDD; MOJo LDD; MegaJOULE LDD is GEX. This falls under the Gastroenterology category.

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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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