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510(k) Data Aggregation
K Number
K230816Device Name
Intense Pulsed Light Treatment System
Manufacturer
Shangdong Huamei Technology Co., Ltd.
Date Cleared
2023-04-21
(28 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shangdong Huamei Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are 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 EROSE-YA device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-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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K Number
K202758Device Name
Nd: YAG Laser Therapy Systems HM-YL900
Manufacturer
Shangdong Huamei Technology Co., Ltd.
Date Cleared
2020-11-16
(56 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shangdong Huamei Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows: 532nm wavelength: * Removal of light ink (red. sky blue, green, purple, and orange) tattoo * Treatment of benign vascular lesions including, but not limited to: telangiectasias, * Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses ( Treatment of Post Inflammatory Hyper-Pigmentation 1064nm wavelength: * Removal dark ink (black, blue and brown) tattoo * Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma. * Removal or lightening of unwanted hair with or without adjuvant preparation * Skin resurfacing procedures for the treatment of acne scars and wrinkles
Device Description
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology.
The Nd: YAG Laser Therapy Systems includes five modules described as following: Control Panel, Main Control Module, Auxiliary Control Module, Laser, laser RF power supply and DC power supply module, Light arm module.
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K Number
K200751Device Name
Photodynamic Therapy (PDT) Equipment
Manufacturer
Shangdong Huamei Technology Co., Ltd.
Date Cleared
2020-05-21
(59 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shangdong Huamei Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The red light (630mm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Device Description
The Photodynamic Therapy (PDT) Equipment HM-PDT 900 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Five sets of LEDs panels are available for the device.
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K Number
K192521Device Name
Intense Pulsed Light Treatment System
Manufacturer
Shangdong Huamei Technology Co., Ltd.
Date Cleared
2019-12-06
(84 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shangdong Huamei Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) 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 HM-IPL-B8 device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200mm. 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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K Number
K192528Device Name
CO2 Laser Therapy System
Manufacturer
Shangdong Huamei Technology Co., Ltd.
Date Cleared
2019-12-03
(81 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shangdong Huamei Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Laser Therapy System is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
The CO2 Laser Therapy System is a carbon dioxide laser used in medical and aesthetic industry. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and and then achieve the indications. The proposed device is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.
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