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FDA 510(k)

PHOTON PHOTON PLUS

K-Number: K122020 · 2013-06-05

ApplicantZolar Technology & Mfg Co., Inc.
Decision Date2013-06-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTON PHOTON PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Zolar Technology & Mfg Co., Inc.. It received FDA 510(k) clearance on 2013-06-05 under 510(k) number K122020. 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 PHOTON PHOTON PLUS?

PHOTON PHOTON PLUS is a medical device that received FDA 510(k) clearance on 2013-06-05. The listed applicant is Zolar Technology & Mfg Co., Inc.. The 510(k) number is K122020.

When did PHOTON PHOTON PLUS receive FDA 510(k) clearance?

PHOTON PHOTON PLUS received FDA 510(k) clearance on 2013-06-05, under 510(k) number K122020.

Who is the listed applicant for PHOTON PHOTON PLUS?

The FDA 510(k) record lists Zolar Technology & Mfg Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOTON PHOTON PLUS?

The FDA product code for PHOTON PHOTON PLUS is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Zolar Technology & Mfg Co., Inc. 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.

K162114Photon, Photon Plus

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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