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510(k) Data Aggregation
K Number
K060234Device Name
MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
Manufacturer
MCCUE PLC
Date Cleared
2006-03-15
(44 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MCCUE PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The McCue 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.
11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Device Description
The McCUE Energist ULTRA VPL™ System is a light based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. 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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K Number
K040659Device Name
MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
Manufacturer
MCCUE PLC
Date Cleared
2004-06-01
(81 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
MCCUE PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. 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 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 long-term or permanent " hair reduction in skin types I - V through selective targeting of melanin in hair follicles.
11 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Device Description
The McCue Energist ULTRA™ is a light-based medical device that delivers a beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The system has been designed to be compact and self-contained that includes: Control console unit Display panel Power supply Cooling system Removable handpiece with integrated switch, lamp, filter and glass coupling block
Ask a Question
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