Dermalife Hydrofusion Skin & Body Care System

510(k) K003916

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK003916	Date15 Apr 2002Cleared	StatusActive

5 recalls · FDA

4 recalls, same reason
- Terminated Z-1603-2009 FDA Unclassified (pre-2012) initiated 22 Jun 2007
- Terminated Z-1605-2009 FDA Unclassified (pre-2012) initiated 22 Jun 2007
- Terminated Z-1604-2009 FDA Unclassified (pre-2012) initiated 22 Jun 2007
- Terminated Z-1602-2009 FDA Unclassified (pre-2012) initiated 22 Jun 2007
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.
- Terminated Z-1245-2009 FDA Unclassified (pre-2012) initiated 15 May 2007
Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns. There were 18 injuries and 8 malfunctions reported.

1 jurisdiction

United States — FDA 510(k) Active

510(k)