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FDA 510(k)

Primelase Excellence

K-Number: K201594 · 2020-12-17

ApplicantHigh Technology Products S.L.U
Decision Date2020-12-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Primelase Excellence is the device name listed in this FDA 510(k) record. The listed applicant is High Technology Products S.L.U. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K201594. 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 Primelase Excellence?

Primelase Excellence is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is High Technology Products S.L.U. The 510(k) number is K201594.

When did Primelase Excellence receive FDA 510(k) clearance?

Primelase Excellence received FDA 510(k) clearance on 2020-12-17, under 510(k) number K201594.

Who is the listed applicant for Primelase Excellence?

The FDA 510(k) record lists High Technology Products S.L.U as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Primelase Excellence?

The FDA product code for Primelase Excellence is GEX. This falls under the Gastroenterology category.

Other records listing High Technology Products S.L.U as applicant

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.

K193367elysion-proK191321Primelase Excellence

Related Devices (Code: GEX)

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.

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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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