510(k) K060191

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT by Accelerated Care Plus Corp. — Product Code ILY

K060191 is an FDA 510(k) premarket notification submitted by Accelerated Care Plus Corp. for the device "ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT". The FDA issued a decision of Substantially Equivalent on July 12, 2006. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Accelerated Care Plus Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2006
Date Received
January 25, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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