510(k) K090250

ELECTRO-LIGHT THERAPY by Hill Laboratories Co. — Product Code ILY

K090250 is an FDA 510(k) premarket notification submitted by Hill Laboratories Co. for the device "ELECTRO-LIGHT THERAPY". The FDA issued a decision of Substantially Equivalent on February 11, 2010. 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
February 11, 2010
Date Received
February 2, 2009
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