Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VHT-200 Wound Treatment System

K-Number: K212121 · 2023-03-23

ApplicantVaporox, Inc.
Decision Date2023-03-23
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VHT-200 Wound Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Vaporox, Inc.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K212121. 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 VHT-200 Wound Treatment System?

VHT-200 Wound Treatment System is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Vaporox, Inc.. The 510(k) number is K212121.

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

VHT-200 Wound Treatment System received FDA 510(k) clearance on 2023-03-23, under 510(k) number K212121.

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

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 VHT-200 Wound Treatment System?

The FDA product code for VHT-200 Wound Treatment System 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.

Related Devices (Code: KPJ)

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.

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.