510(k) K070400

LC THERAPY, MODEL LCT-1000 by Litecure, LLC — Product Code ILY

K070400 is an FDA 510(k) premarket notification submitted by Litecure, LLC for the device "LC THERAPY, MODEL LCT-1000". The FDA issued a decision of Substantially Equivalent on February 28, 2007. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Litecure, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2007
Date Received
February 12, 2007
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