Cleared Traditional

AXON IR Heat Lamp

K171087 · Crystal Medtech, LLC · Physical Medicine

Jul 2017

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K171087 is an FDA 510(k) clearance for the AXON IR Heat Lamp, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Crystal Medtech, LLC (Schofield, US). The FDA issued a Cleared decision on July 7, 2017, 86 days after receiving the submission on April 12, 2017. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K171087 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2017
Decision Date	July 07, 2017
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF