FDA 510(k)

Wound Treatment System (VHT-200)

K-Number: K250188 · 2025-03-10

Decision Date2025-03-10

Product CodeKPJ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Wound Treatment System (VHT-200) is the device name listed in this FDA 510(k) record. The listed applicant is Vaporox, Inc.. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K250188. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wound Treatment System (VHT-200)?

Wound Treatment System (VHT-200) is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Vaporox, Inc.. The 510(k) number is K250188.

When did Wound Treatment System (VHT-200) receive FDA 510(k) clearance?

Wound Treatment System (VHT-200) received FDA 510(k) clearance on 2025-03-10, under 510(k) number K250188.

Who is the listed applicant for Wound Treatment System (VHT-200)?

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

What is the FDA product code for Wound Treatment System (VHT-200)?

The FDA product code for Wound Treatment System (VHT-200) is KPJ.

Other records listing Vaporox, 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.

K212121VHT-200 Wound Treatment System

Related Devices (Code: KPJ)

K212121VHT-200 Wound Treatment SystemVaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba Ogenix

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.