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FDA 510(k)

HyPHo Laser System

K-Number: K163449 · 2017-06-23

ApplicantHyper Photonics Srl
Decision Date2017-06-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HyPHo Laser System is a medical device manufactured by Hyper Photonics Srl. It received FDA 510(k) clearance on 2017-06-23 under approval number K163449. 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 HyPHo Laser System?

HyPHo Laser System is a medical device that received FDA 510(k) clearance on 2017-06-23. It is manufactured by Hyper Photonics Srl. The 510(k) number is K163449.

When was HyPHo Laser System approved by the FDA?

HyPHo Laser System received FDA 510(k) clearance on 2017-06-23, under approval number K163449.

What company makes HyPHo Laser System?

HyPHo Laser System is manufactured by Hyper Photonics Srl.

What is the FDA product code for HyPHo Laser System?

The FDA product code for HyPHo 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)

Related Devices (Code: GEX)

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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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