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510(k) Data Aggregation
K Number
K240809Device Name
LUOFUCON® Silver Collagen Dressing
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-12-16
(266 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds
Device Description
LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.
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K Number
K242856Device Name
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-11-13
(54 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.
Device Description
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.
- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.
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K Number
K240485Device Name
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-10-07
(230 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.
Device Description
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus is a soft, conformable, sterile dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and polyethylene terephthalate fibers, 1.1% (w/w) ionic silver, and stitched with lyocell fibers. This conformable dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
The silver ions help to inhibit microbial growth in the dressing for up to seven days. Additionally, based on in vitro testing, LUOFUCON® Extra Silver Gelling Fiber Dressing Plus also provides a barrier against bacterial penetration.
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K Number
K232796Device Name
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-04-25
(226 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUOFUCON® Collagen Particles is intended for the management of wounds including:
- · Full thickness and partial thickness wounds
- · Pressure (stage I-IV) and venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Venous stasis and diabetic ulcers
- · 1st and superficial second-degree burns
- Cuts
- Abrasions
- · Surgical wounds
Device Description
LUOFUCON® Collagen Particles is a native bovine collagen wound dressing that is sterile, white to off-white, absorbent and resorbable powder. LUOFUCON® Collagen Particles maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other suitable secondary dressings indicated for wound management. The device is intended for one time use.
LUOFUCON® Collagen Particles is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
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K Number
K223360Device Name
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-03-27
(510 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription Use: LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use: LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Device Description
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.
- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.
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K Number
K221110Device Name
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-01-04
(629 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription use:
Under the supervision of a healthcare professional:
LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the management of surgical wounds as an effective barrier to microbial penetration of the dressing.
OTC use:
LUOFUCON® Antibacterial Gelling Fiber Cover Dressing may be used for: Minor abrasions: Minor lacerations; Minor cuts; Minor scalds and burns.
Device Description
LUOFUCON® Silver Gelling Fiber Surgical Dressing is a sterile post-operative dressing, comprising of polyurethane film, super absorbent fiber non-woven pad, silver gelling fiber non-woven pad (wound contact) containing 1.1% (w/w) ionic silver, and silicone qel. A windowed self-adhesive silicone skin contact layer plays a role of minimizing the trauma on removal, and alleviating the leakage of exudate.
The compliance and the softness of the dressing are improved effectively by using the notched non-woven pad, thus it is easier to apply on the wounds/parts which are difficult to paste. The highly absorbent dressing has a strong exudate management. When absorbing the wound fluid, the dressing will form a soft gel to support a moist wound healing environment. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.
Based on in vitro performance data, the LUOFUCON® Silver Gelling Fiber Surgical Dressing is waterproofness and breathable. The polyurethane film of dressing provides a microbial barrier to prevent the microbial penetrating through it, and the silver component prevents the growth of the bacteria within the dressing up to 7 days.
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K Number
K223359Device Name
LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2023-12-21
(413 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription Use:
LUOFUCON® Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial second- degree burns, donor sites, surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Device Description
LUOFUCON® Aq+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing is a sterile, single-use wound dressing. The device has a single or multi-layer structure and its foam layer is containing 0.40mg/cm² maximum content of ionic silver. According to the different composition of product structure, the device provides three models: Easy, Backing and Adhesive.
- (a) The first model, Easy, consist of a single exudate absorption layer (Polyurethane foam containing silver compound).
- (b) The second model, Backing, consist of a backing layer (Polyurethane film); an exudate absorption layer (Polyurethane foam containing silver compound).
- (c) The third model, Adhesive, consist of a self-adhesive layer (Adhesive tape); an exudate absorption layer (Polyurethane foam containing silver compound); a release liner covers on the adhesive tape.
Depending on its exudate absorption layer, the device can absorb wound exudates and maintain a moist wound healing environment. As wound exudates are absorbed, the silver ions released from the polyurethane foam to assist in inhabiting bacterial growth within the dressing for up to 7days, as demonstrated in vitro. The polyurethane film of dressing is waterproof and breathable which can provide a microbial barrier to prevent the microbial penetrating through it.
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K Number
K213598Device Name
LUOFUCON Collagen Wound Dressing
Manufacturer
Huizhou Foryou Medical Devices CO., Ltd.
Date Cleared
2022-09-20
(309 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions.
The dressing can be cut to the exact size of the wound, and can be used in multiple layers.
Device Description
LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing.
When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing.
LUOFUCON® Collagen Wound Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.
LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
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K Number
K211123Device Name
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
Manufacturer
Huizhou Foryou Medical Devices CO., Ltd.
Date Cleared
2022-04-22
(372 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.
Device Description
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).
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K Number
K210718Device Name
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2022-03-23
(378 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Huizhou Foryou Medical Devices Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription:
LUOFUCON® Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.
Device Description
LUOFUCON® Extra Silver Gelling Fiber Dressing is a soft, conformable, non-woven pad or ribbon dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and Polyethylene terephthalate fibers and 1.1% (w/w) ionic silver. Based on in vitro testing, the silver in the dressing inhibits bacterial growth in the dressing and provides a barrier against bacterial penetration through the dressing for up to seven days. This conformable and highly absorbent dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
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