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510(k) Data Aggregation
K Number
K090744Device Name
CLARO
Manufacturer
Date Cleared
2010-04-15
(391 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CLRS TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Device Description
The CLARO is a portable handheld intense pulse light (IPL) device powered by a rechargeable battery. The CLARO uses a Xenon flash lamp which delivers pulses of light with a wavelength range from 400-1100 nm at Imsec pulse duration and a fluence of 6 J/cm2. The spot size of the CLARO is 1cm2.
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K Number
K080638Device Name
CLARO
Manufacturer
Date Cleared
2008-09-17
(195 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CLRS TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Device Description
The CLARO is a portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp. The device is powered by a rechargeable battery. CLARO is intended to be a prescription device which will be used both in the doctor's office and in the home environment for the treamment of mild to moderate acne.
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