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510(k) K040121

DERMAWAVE 5000 COMBI MAX SYSTEM by Dermawave, LLC — Product Code IMG

K040121 is an FDA 510(k) premarket notification submitted by Dermawave, LLC for the device "DERMAWAVE 5000 COMBI MAX SYSTEM". The FDA issued a decision of Substantially Equivalent on March 17, 2004. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2004
Date Received
January 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

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FDA data resources