510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003916Substantially Equivalent

Dermalife Hydrofusion Skin & Body Care System

Scandia Manufacturing, Ltd., Bloomington MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003916 is the FDA 510(k) clearance record for DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM, a class II device, cleared for Scandia Manufacturing , Ltd. on under FDA product code IMB (Cabinet, Moist Steam). FDA records list one 510(k) clearance for Scandia Manufacturing , Ltd. As of , FDA records show 5 recalls naming K003916.

Clearance record

Decision date
Received
(482 days to decision)
Product code
IMB Cabinet, Moist Steam
Regulation
21 CFR 890.5250
Device class
Class II
Review panel
Physical Medicine
Applicant
Scandia Manufacturing , Ltd. 9220 James Ave. S., Bloomington MN
510(k) summary
Statement
Third party review
No

Clearances, product code IMB

Trailing 12 months

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

FDA records show no clearances under product code IMB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IMB, 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