Atlas FDA

DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM

FDA 510(k) clearance K003916 · decided 2002-04-15

Clearance details

K-number
K003916
Device name
DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
Applicant
Scandia Manufacturing , Ltd.
Decision
Substantially Equivalent
Date received
2000-12-19
Decision date
2002-04-15
Days to decision
482 days
Clearance type
Traditional
Product code
IMB
Device class
2
Regulation number
890.5250
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Bloomington, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD recall (Z-1245-2009)Sybaritic, Inc2009-07-15
DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the S recall (Z-1602-2009)Sybaritic, Inc2009-07-13
DERMALIFE Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G;100V 50/60Hz. This is th recall (Z-1603-2009)Sybaritic, Inc2009-07-13
DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oc recall (Z-1604-2009)Sybaritic, Inc2009-07-13
DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet prod recall (Z-1605-2009)Sybaritic, Inc2009-07-13