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510(k) Data Aggregation
K Number
K140668Device Name
PLATINUMGMT IPL SYSTEM CLOUD
Manufacturer
GLOBAL MEDICAL TECHNOLOGY S.L.
Date Cleared
2014-12-19
(276 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL MEDICAL TECHNOLOGY S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and 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 PlatinumGMT™ IPL System Cloud device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 560 nm-1200 nm. 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 PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions.
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