Search Results
Found 1 results
510(k) Data Aggregation
K Number
K093168Device Name
MEDIFLASH AND ESTEFLASH
Manufacturer
Date Cleared
2010-05-21
(226 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DERMEO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: Intense Pulsed Light Energy/Wavelengths (420nm-1200nm) - . 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 for Fitzpatrick Skin types I-III (Wavelengths - 515 - 1200 nm, or 500 -600 and 870 - 1200nm) - The treatment of benign pigmented epidermal and cutaneous lesions including scars and . striae for Fitzpatrick Skin types I-III (Wavelengths -550- 1200 nm) - Treatment of inflammatory acne (acne vulgaris) for Fitzpatrick Skin types I-III . (Wavelengths 420 - 1200 nm) - Removal of unwanted hair from all skin types and to effect stable long term or . permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 – 1200 nm). MEDIFLASH3 cannot be used for skin type VI. *Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime. The ESTHEFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: - . Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). ESTHEFLASH 3 cannot be used for skin type VI. *Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.
Device Description
The MEDIFLASH3 and ESTHEFLASH3 Intense Pulsed Light Device Systems are light based medical devices that deliver a flash of pulsed non-ionizing radiation within the spectral range covering 400 to 1200 nanometers. The system is designed to be compact and self contained and includes the following features: - t Control console unit - Display panel . - Power supply . - . Cooling system - Hand piece with detachable cartridge with lamp, mirror and filter .
Ask a Question
Ask a specific question about this device
Page 1 of 1