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510(k) Data Aggregation
K Number
K240052Device Name
Disposable Enteral Feeding Sets
Manufacturer
Beijing L&Z Medical Technology Development Co., Ltd.
Date Cleared
2024-07-03
(177 days)
Product Code
PIF
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Beijing L&Z Medical Technology Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents, and adults.
Device Description
The proposed device, Disposable Enteral Feeding Sets, is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults. The proposed device is provided sterile or non-sterile and single use.
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K Number
K231218Device Name
Distal Access Catheter
Manufacturer
AccuMedical Beijing Ltd.
Date Cleared
2024-01-19
(266 days)
Product Code
QJP, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
AccuMedical Beijing Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
Device Description
The Distal Access Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Distal Access Catheter has a radiopaque marker on the distal tip that is visible under fluoroscopy. The Distal Access Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has a straight tip. The catheter is offered in various lengths to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
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K Number
K222622Device Name
Disposable Infusion Bag for Parenteral Nutrition
Manufacturer
Beijing L&Z Medical Technology Development Co., Ltd.
Date Cleared
2023-02-16
(169 days)
Product Code
KPE
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
Beijing L&Z Medical Technology Development Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
The device is not intended to store the fluids for 24 hours or greater.
Device Description
The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.
The proposed device is available in 7 series due to different bag capacities, different tube locations and different tube materials.
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K Number
K220381Device Name
Diode Laser Therapy Systems
Manufacturer
Beijing LaserTell Medical Co., Ltd.
Date Cleared
2022-05-20
(99 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing LaserTell Medical Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser Therapy Systems is intended for hair removal, permanent 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
Diode Laser Therapy Systems is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); The Diode Laser Therapy Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handpiece. The emission laser is activated by a foot-switch. The Diode Laser Therapy Systems utilize the principle of photoepilation for hair removal. The Photoepilation is a technique for removal of unwanted hair by thermal destruction of the hair follicle and its reproductive system (stems cells). The heat is caused by selective absorption of electromagnetic radiation emitted by laser light sources. As melanin is the main chromophore existing in hair follicles, so the melanin could absorb the energy from the laser, which would result in temperature rapid increase, then the hair follicle and its reproductive system (stems cells) would be destroyed by increased high temperature without damage epidermis and the surrounding normal tissue.
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K Number
K192735Device Name
Diode Laser Hair Removal Machine
Manufacturer
Beijing Lead Beauty S & T Co., Ltd
Date Cleared
2020-04-03
(189 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Lead Beauty S & T Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), 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 Hair Removal Machine, 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.
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K Number
K193609Device Name
Q Switched Nd: YAG Laser machine
Manufacturer
Beijing Lead Beauty S & T Co., Ltd
Date Cleared
2020-03-20
(85 days)
Product Code
GEX, DAT
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Beijing Lead Beauty S & T Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, 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 proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired waveleneth and the related output energy via control panel.
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K Number
K132642Device Name
LOCKING PLATE SYSTEM
Manufacturer
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD
Date Cleared
2013-10-03
(38 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur tibia and fibula.
Device Description
The proposed products, Locking Plate System, contain (1) locking plates (1.Ps) with various specifications. (2) locking screws with various specifications and (3) various specific instruments. Locking Plates are the plates that made of Titanium. The limited-contact design of LPs reduces plate-to-bone contact, thus limiting vascular trauma. The screws are available in three kinds, which are 3.5mm Hexagonal Locking Screws with hexagonal interface, 3.5mm Stardrive Locking Screws with Torx interface, and 5.0mm Locking Screws with hexagonal interface. There are various instruments specific to the proposed device intend for completing the surgery.
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