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510(k) Data Aggregation
K Number
K082197Device Name
RHYTEC, INC., PORTRAIT PSR
Manufacturer
RHYTEC INCORPORATED
Date Cleared
2008-08-22
(18 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RHYTEC INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides
- Superficial skin lesions
- Actinic Keratosis
- Viral Papillomata
- Seborrhoeic Keratosis
- Acne Scars
Device Description
The Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based and RF-based dermatological surgical and skin resurfacing technologies.
The system includes:
- Portrait PSR3 Generator a mobile unit comprising a trolley and lift-out section referenced to as a "generator section". Treatment parameters are displayed on the control panel. The unit is powered by a 110/230 VAC standard wall socket.
- Footswitch - single pedal unit for activation
- Handpiece and Cable Assembly carries RF power and Nitrogen gas to the Nozzle.
- Treatment Pack comprising a disposable Nozzle that is connected to the Handpiece and an electronic "treatment pack key" that is used by the generator to ensure the Nozzle is not used beyond its validated operational life. The instrument does not touch the skin during treatment.
- Nitrogen Gas Cylinder -- the gas is provided in a cylinder housed in the generator enclosure. Refill cylinders containing the required purity of Nitrogen are obtained by the user from a commercial gas supplier.
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K Number
K073111Device Name
PORTRAIT PSR, MODEL 745915
Manufacturer
RHYTEC INCORPORATED
Date Cleared
2008-03-27
(143 days)
Product Code
GEI, POR
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RHYTEC INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides
- Superficial skin lesions
- Actinic Keratosis
- Viral Papillomata
- Seborrhoeic Keratosis
- Acne Scars
Device Description
The Portrait® PSR is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based dermatological surgical and skin resurfacing technologies.
The system includes:
- Portrait® PSR3 Generator
- Footswitch
- Handpiece and Cable Assembly
- Treatment Pack comprising a disposable Nozzle and an electronic "treatment pack key"
- Nitrogen Gas Cylinder
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K Number
K072394Device Name
PORTRAIT STAND-OFF
Manufacturer
RHYTEC INCORPORATED
Date Cleared
2007-09-12
(16 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RHYTEC INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides .
- Superficial skin lesions .
- Actinic Keratosis .
- Viral Papillomata .
- Seborrhoeic Keratosis .
The indications are unchanged from K071886.
Device Description
The Rhytec, Inc. Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts itrogen gas into plasma within the Handpiece. The plasma emerges from the Nozzle at the distal end of the Handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the Handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predicy able tissue effects. The detachable Nozzle Stand-off (distance gauge) assists the user in maintaining the proper distance between the Nozzle and the skin.
The modification is a reusable/disposable Standoff distance gauge accessory to the Portrait® PSR3 system.
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K Number
K071786Device Name
PORTRAIT PSR
Manufacturer
RHYTEC INCORPORATED
Date Cleared
2007-07-26
(24 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RHYTEC INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portrait® PSR³ is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides
- Superficial skin lesions
- Actinic Keratosis
- Viral Papillomata
- Seborrhoeic Keratosis
Device Description
The Portrait® PSR³ is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nittrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
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K Number
K060948Device Name
PORTRAIT PSR3
Manufacturer
RHYTEC INCORPORATED
Date Cleared
2006-09-05
(152 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RHYTEC INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portrait PSR3 is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides .
- . Superficial skin lesions
- . Actinic Keratosis
- . Viral Papillomata
- . Seborrhoeic Keratosis
Device Description
The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
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