510(k) K110342

YOLO CURVE by Yolo Medical, Inc. — Product Code ILY

K110342 is an FDA 510(k) premarket notification submitted by Yolo Medical, Inc. for the device "YOLO CURVE". The FDA issued a decision of Substantially Equivalent on August 22, 2011. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Yolo Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2011
Date Received
February 4, 2011
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