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510(k) Data Aggregation
K Number
K992630Device Name
THERMALIGHT 2000
Manufacturer
Date Cleared
1999-09-10
(87 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
JENNIFERMAXX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The THERMALIGHT®® 2000 is indicated for removal of unwanted body hair through the application of pulsed light energy applied to the hair follicle at the surface of the skin (non-invasive photo-epilation).
Device Description
The Thermalight2000 is an instrument which is designed to painlessly, safely, and effectively remove hair by the application of pulsed light energy to the hair follicle. It operates similar to needle electrolysis machine in that it removes hair, one hair at a time by thermolysis. Using the Thermalight2000, thermolysis is achieved by the application of light energy to the hair growth support tissue instead of the application of electrical energy employed by conventional needle electrolysis units.
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