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FDA 510(k)

Photodynamic Therapy Device

K-Number: K170187 · 2017-07-28

ApplicantUvbiotek, LLC
Decision Date2017-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Photodynamic Therapy Device is a medical device manufactured by Uvbiotek, LLC. It received FDA 510(k) clearance on 2017-07-28 under approval number K170187. 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 Photodynamic Therapy Device?

Photodynamic Therapy Device is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Uvbiotek, LLC. The 510(k) number is K170187.

When was Photodynamic Therapy Device approved by the FDA?

Photodynamic Therapy Device received FDA 510(k) clearance on 2017-07-28, under approval number K170187.

What company makes Photodynamic Therapy Device?

Photodynamic Therapy Device is manufactured by Uvbiotek, LLC.

What is the FDA product code for Photodynamic Therapy Device?

The FDA product code for Photodynamic Therapy Device is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (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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