Cleared Traditional

CytonPro-5000

K213524 · Cytonsys, Inc. · Physical Medicine

Aug 2022

Decision

280d

Days

Class 2

Risk

About This 510(k) Submission

K213524 is an FDA 510(k) clearance for the CytonPro-5000, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Cytonsys, Inc. (Austin, US). The FDA issued a Cleared decision on August 10, 2022, 280 days after receiving the submission on November 3, 2021. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K213524 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2021
Decision Date	August 10, 2022
Days to Decision	280 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF