510(k) K121487

LITECURE THERAPY COMPACT by Litecure, LLC — Product Code ILY

K121487 is an FDA 510(k) premarket notification submitted by Litecure, LLC for the device "LITECURE THERAPY COMPACT". The FDA issued a decision of Substantially Equivalent on June 12, 2012. 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
June 12, 2012
Date Received
May 18, 2012
Clearance Type
Special
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