Cleared Traditional

K083183 - AKLARUS PHOTOTHERAPY SYSTEM
(FDA 510(k) Clearance)

K083183 · Hill Laboratories Co. · Physical Medicine

Jul 2009

Decision

261d

Days

Class 2

Risk

K083183 is an FDA 510(k) clearance for the AKLARUS PHOTOTHERAPY SYSTEM, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Hill Laboratories Co. (Frazer, US). The FDA issued a Cleared decision on July 16, 2009, 261 days after receiving the submission on October 28, 2008. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K083183 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2008
Decision Date	July 16, 2009
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF