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510(k) Data Aggregation
K Number
K210168Device Name
Diode Laser Therapy Systems
Manufacturer
Beijing Kes Biology Technology CO., LTD.
Date Cleared
2021-05-10
(108 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Kes Biology Technology CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser Therapy Systems are intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
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 regime.
Device Description
The proposed device, Diode Laser Therapy System, is a surgical device. It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black); in addition, the treatment can also be applied to different parts of the body, such as arm, chest, leg, underarm etc.
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K Number
K193477Device Name
Nd: YAG Laser Therapy Systems
Manufacturer
Beijing Kes Biology Technology Co., Ltd.
Date Cleared
2020-06-24
(191 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Kes Biology Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm wavelength:
-Tattoo removal: light ink(red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
Device Description
The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce 1064nm and 532nm two different laser wavelengths to treat the different color skin. It consists of power supply module, microprocessor control module, laser treatment handpiece module, operation display module and cooling system module. The physician is able to select the desired wavelength and the related output energy via control panel.
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K Number
K122995Device Name
INTENSE PULSED LIGHT (IPL) SYSTEMS
Manufacturer
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
Date Cleared
2013-01-22
(118 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING KES BIOLOGY TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light (IPL) Systems (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides (freckles), and vascular lesions.
Device Description
The Intense Pulsed Light (IPL) Systems are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 430nm-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.
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