Cleared Traditional

VHT-200 Wound Treatment System

K212121 · Vaporox, Inc. · General & Plastic Surgery

Mar 2023

Decision

624d

Days

Class 2

Risk

About This 510(k) Submission

K212121 is an FDA 510(k) clearance for the VHT-200 Wound Treatment System, a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Vaporox, Inc. (Centennial, US). The FDA issued a Cleared decision on March 23, 2023, 624 days after receiving the submission on July 7, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.

Submission Details

510(k) Number	K212121 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2021
Decision Date	March 23, 2023
Days to Decision	624 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF