510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K040121Substantially Equivalent

Dermawave 5000 Combi Max System

Dermawave, LLC, Loxahatchee FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040121 is the FDA 510(k) clearance record for DERMAWAVE 5000 COMBI MAX SYSTEM, a class II device, cleared for Dermawave, LLC on under FDA product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat). FDA records list one 510(k) clearance for Dermawave, LLC. As of , FDA records show no recalls naming K040121.

Clearance record

Decision date
Received
(57 days to decision)
Product code
IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Regulation
21 CFR 890.5860
Device class
Class II
Review panel
Physical Medicine
Applicant
Dermawave, LLC 15693 83rd Ln. N., Loxahatchee FL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code IMG

Trailing 12 months

FDA records hold no clearances under product code IMG in the trailing twelve months.

FDA records show no clearances under product code IMG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260