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510(k) Data Aggregation
K Number
K132754Device Name
NEOGEN PSR SYSTEM
Manufacturer
ENERGIST, LTD.
Date Cleared
2013-12-12
(100 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENERGIST, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NeoGen PSR System is intended for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides .
- Superficial skin lesions .
- Actinic Keratosis .
- Viral Papillomata .
- Seborrheic Keratosis .
- Acne Scars .
Device Description
The NeoGen System is an electro-surgical device intended for use in dermatological applications by trained and duly qualified medical practitioners in hospitals and clinics. Treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis. Similar biological changes to those from established laser-based dermatological surgical and skin resurfacing technologies are produced. A NeoGen PSR system comprises: NeoGen PSR generator, Footswitch, Handpiece/Cable Assembly, Procedure Pack (disposable nozzles), Nitrogen gas cylinder (not supplied). 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.
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K Number
K082825Device Name
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
Manufacturer
ENERGIST, LTD.
Date Cleared
2009-02-06
(134 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ENERGIST, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- Intense Pulsed Light Energy / wavelengths (530 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for: The treatment of mild to moderate inflammatory Acne Vulgaris. The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins, facial veins and venous malformations.
Intense Pulsed Light Energy / wavelengths (610 - 950nm)
The 610 - 950nm intense pulsed wavelengths are indicated for: The removal of unwanted hair from all skin types and to effect stable longterm or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
* Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Intense Pulsed Light Energy/wavelengths (415/630 - 950nm) 1 The treatment of mild to moderate inflammatory Acne Vulgaris.
Device Description
Not Found
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K Number
K060216Device Name
ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
Manufacturer
ENERGIST, LTD.
Date Cleared
2006-03-16
(48 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ENERGIST, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Energist ULTRA™ VPL Intense Pulsed Light System is intended for permanent hair reduction and the treatment of mild to moderate inflammatory Acne Vulgaris. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the treatment of benign pigmented lesions.
- Intense Pulsed Light Energy / wavelengths (530 - 950nm) .
The 530 - 950nm intense pulsed wavelengths are indicated for:
The treatment of mild to moderate inflammatory Acne Vulgaris.
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea. melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins. facial veins and venous malformations.
Intense Pulsed Light Energy / wavelengths (610 - 950nm) .
The 610 - 950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types and to effect stable longterm or permanent 1 hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Device Description
The Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm. The system is designed to be compact and self contained and includes the following features:
- . Control console unit
- Display panel .
- Power supply ◆
- Cooling system .
- . Removable handpiece with integrated switch, lamp, filter and glass coupling block
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