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510(k) Data Aggregation
K Number
K162398Device Name
CO2 Laser Therapy Systems
Date Cleared
2017-07-06
(314 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.
Device Description
The CO2 Diode Laser Therapy Systems mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin is the main target of the CO2 fractional laser, after absorbed the energy of the laser, the water will release heat, then be evaporated and gasified immediately, the cutaneous lesion will be eliminated instantly. By setting up the suitable energy and other parameters on skin tissue based on its specific thermal relaxation time, the healthy tissue can be prevented from being harmed.
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K Number
K163123Device Name
Q-Switched Nd:YAG Laser Therapy Systems
Date Cleared
2017-02-02
(86 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING SINCOHEREN SCIENCE AND TECHNOLOGY DEVELOPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated 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 as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Device Description
The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.
The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.
The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.
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K Number
K152898Device Name
DIODE LASER THERAPY SYSTEMS
Date Cleared
2016-02-09
(131 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING SINCOHEREN SCIENCE AND TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 Diode Laser Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.
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K Number
K123435Device Name
IPL THERAPY SYSTEM
Manufacturer
Date Cleared
2013-02-11
(96 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intense pulsed light therapy system is indicated for use in surgical, aesthetic and cosmetic application in the hair removal at a wavelength ranging from 690-1200nm.
Device Description
The IPL Therapy Systems is an Intense Pulsed Light Therapy System which delivers intense pulsed light at a wavelength ranging from 690nm -1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is causing thermal damage to target chromophores by using light of appropriated 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 Therapy System is 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. The Sincoheren IPL Therapy system controlled by computer is composed: - Main unit - LCD monitor - Treatment handle . The embedded microprocessor monitors can control the system continually. The operating Interface includes a full-LCD screen (8.0 inch), the key switch and emergency shut-off knob. LCD screen both shows the system work program, treatment parameters and number of light emitting. The treatment handle operated by hand comprises the intense emitter and transmission system.
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