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510(k) Data Aggregation
K Number
K241916Device Name
TearRepair Liquid Skin Protectant
Manufacturer
OptMed, Inc.
Date Cleared
2024-09-27
(88 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
OptMed, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.
Device Description
TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.
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K Number
K141157Device Name
BONDEASE TOPICAL SKIN ADHESIVE
Manufacturer
OPTMED, INC.
Date Cleared
2015-12-22
(596 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
OPTMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BondEase® Topical Skin Adhesive is intended for topical use only, to hold together the skin edges of incisions and lacerations that are under minimal tension and easily approximated. Where significant tension exists on incisions or lacerations, BondEase® Topical Skin Adhesive should be used in conjunction with deep dermal stiches.
Device Description
BondEase® Topical Skin Adhesive is a sterile, liquid topical skin closure device composed of a methylidene malonate monomer formulation and the colorant D&C Green #6. It is provided in a single-use applicator, packaged in a foil pouch. The applicator is comprised of a crushable glass ampoule contained within a plastic vial with attached applicator tip and handle. BondEase® is applied to the skin as a viscous liquid which polymerizes to bond approximated wound edges within minutes. In vitro studies have shown that BondEase® acts as a bacterial barrier as long as the adhesive film remains intact.
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