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510(k) Data Aggregation
K Number
K043032Device Name
DEALIGHT IPL
Manufacturer
Date Cleared
2005-07-19
(258 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EUROPRO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for: The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, 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 re-growing after a treatment regimen.
Device Description
The Dealight Intense Pulsed Light (IPL) is comprised of the following main components: - A light / laser system console (including software and control electronics) - A control and display panel - Air cooling system - A hand-piece with cut off filters -
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