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510(k) Data Aggregation
K Number
K241670Device Name
Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
Manufacturer
Beijing ADSS Development Co., Ltd.
Date Cleared
2024-12-20
(192 days)
Product Code
GEX
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
Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology plastic surgery and general surgery.
Device Description
Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.
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K Number
K233307Device Name
Intensity Pulsed Light Therapy System
Manufacturer
Beijing ADSS Development Co., Ltd.
Date Cleared
2024-03-15
(168 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 Intensity Pulsed Light Therapy System is intended for medical use in the treatment of the following conditions: -Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); -Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. -Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
Device Description
Not Found
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K Number
K231896Device Name
Diode Laser Therapy System
Manufacturer
Beijing ADSS Development Co., Ltd.
Date Cleared
2024-02-20
(237 days)
Product Code
GEX
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 Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Device Description
The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.
The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.
The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.
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K Number
K231318Device Name
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
Manufacturer
Beijing ADSS Development Co., Ltd.
Date Cleared
2023-07-07
(60 days)
Product Code
NGX
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Beijing ADSS Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks and thighs.
Device Description
The Electromagnetic stimulator device consists of a host, hand tools and power cord. The host contains a power supply unit, a control unit, and a cooling unit. The control unit includes a control element and a liquid crystal display. The hand tools include electromagnetic induction coils and cooling fans, it is a non-invasive therapeutic device.
The subject device has two models, Tesla Duet and EM contouring. The two models are exactly the same except for the color of the host shell, one is black and other is white.
The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the Electromagnetic stimulator device helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The Electromagnetic stimulator device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
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K Number
K220268Device Name
Picosecond Laser System (Model PS10-A and PS10-B)
Manufacturer
Beijing ADSS Development Co., Ltd.
Date Cleared
2022-08-23
(204 days)
Product Code
GEX
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 Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Device Description
The Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device.
The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).
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K Number
K192295Device Name
PDT-FACE
Manufacturer
Beijing ADSS Development Co., Ltd.
Date Cleared
2020-05-01
(252 days)
Product Code
OLP, OHS
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 red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.
Device Description
The LED THERAPY DEVICE is a facemask-shaped device, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics. The proposed device has total of 150 LEDs and operates in two modes. One mode emits blue light with wavelengths centered at 415nm ±5nm, and the other mode emits red light with wavelengths centered at 630nm ±5nm. The red light is intended for the treatment of wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The blue light mode has ten level energy output settings, 5mw/cm2-50mw/cm2. The red light mode has ten level energy output settings, 8mw/cm2-80mw/cm2. The user can change the treatment mode according to their own needs. The LED THERAPY DEVICE is powered via a plug-in power adapter.
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