Sybaritic, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 9
At a glance
Market reach
- United States
- FDA recalls
What Sybaritic, Inc. makes
Sybaritic, Inc. manufactures the DermoSonic Non-Invasive Subdermal Therapy System, a device designed for targeted, non-invasive treatment of the subdermal layer of skin.
The company’s portfolio is regulated under FDA Class II devices and includes submissions via the 510(k) pathway. The device is based in the United States.
Catalogue
Dermosonic Non-Invasive Subdermal Therapy System Ref K024307
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 9 recalls initiated by Sybaritic, Inc., the earliest on 2005-01-05 and the most recent on 2008-06-18. By recorded status: 9 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 18 Jun 2008 Z-1308-2009 Unclassified (pre-2012) Terminated Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.
- 18 Jun 2008 Z-1423-2009 Unclassified (pre-2012) Terminated Misbranded and sale without pre-market notification.
- 12 Apr 2008 Z-1444-2009 Unclassified (pre-2012) Terminated Sybaritic Inc. had an issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.
Full distribution text
2007
- 22 Jun 2007 Z-1602-2009 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 22 Jun 2007 Z-1603-2009 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 22 Jun 2007 Z-1604-2009 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 22 Jun 2007 Z-1605-2009 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 15 May 2007 Z-1245-2009 Unclassified (pre-2012) Terminated 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.
Full distribution text
- 22 Jun 2007 Z-1602-2009 Unclassified (pre-2012) Terminated 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.
2005
- 5 Jan 2005 Z-0578-05 Unclassified (pre-2012) Terminated Device is performing functions that are not cleared in the 510(k).
Full distribution text
- 5 Jan 2005 Z-0578-05 Unclassified (pre-2012) Terminated Device is performing functions that are not cleared in the 510(k).
Frequently asked questions
How many devices does Sybaritic, Inc. have in the registry?
The registry currently lists 1 device for Sybaritic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sybaritic, Inc.'s devices?
Among its 1 most recently registered device, Sybaritic, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sybaritic, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sybaritic, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sybaritic, Inc.?
FDA recall records list 9 recalls initiated by Sybaritic, Inc., the most recent initiated on 18 Jun 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sybaritic, Inc. in the registry?
The most recently registered devices listed for Sybaritic, Inc. include DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM.