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510(k) Data Aggregation
K Number
K161286Device Name
IPL Therapy Machine
Manufacturer
BEIJING ADSS DEVELOPMENT CO., LTD
Date Cleared
2016-08-04
(87 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING ADSS DEVELOPMENT CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions.
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 VE2000 device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.
Based on this,The VE2000 device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, reduction of pigmented lesions and vascular lesions.
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