510(k) K083183

AKLARUS PHOTOTHERAPY SYSTEM by Hill Laboratories Co. — Product Code ILY

K083183 is an FDA 510(k) premarket notification submitted by Hill Laboratories Co. for the device "AKLARUS PHOTOTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 16, 2009. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Hill Laboratories Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2009
Date Received
October 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type