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510(k) Data Aggregation
K Number
K250465Device Name
CO2 Laser Machine (Lume)
Manufacturer
Nanjing Bestview Laser S&T Co., Ltd.
Date Cleared
2025-06-09
(111 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Bestview Laser S&T Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.
Device Description
The CO2 Laser Machine generate a 10,600nm wavelength, which is absorbed by water in the tissue.
The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).
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K Number
K242440Device Name
Intense Pulsed Light Treatment System (LK-PT)
Manufacturer
Nanjing Bestview Laser S&T Co., Ltd.
Date Cleared
2024-11-14
(90 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Bestview Laser S&T Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light Treatment System (Model: LK-PT) is indicated for use in surgical and aesthetic applications in permanent hair removal, 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 LK-PT device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 560mm ~ 1200nm. Intense Pulsed Light(IPL) system 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.
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