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510(k) Data Aggregation
K Number
K141986Device Name
ELUX 810 LASER
Manufacturer
Date Cleared
2015-01-30
(192 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EQUIPMED NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ELux810 Laser is indicated for hair removal, permanent hair reduction in people with Fitzpatrick skin type I-V. It is also indicated for the treatment of benign superficial vascular and benign superficial pigmented lesions in people with Fitzpatrick skin type I-IV. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
Device Description
The ELux810 Laser is a diode laser of 808nm system. This device is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to use in various treatments by effecting to skin by laser beam of 808nm generated from laser diode. Diode laser of CW system is able to transfer stable and uniform pulses to skin, therefore medical doctor can treat patient safely and effectively using this equipment.
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