510(k) K051261

DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE by Dynatronics Corp. — Product Code ILY

K051261 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE". The FDA issued a decision of Substantially Equivalent on July 25, 2005. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2005
Date Received
May 16, 2005
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