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510(k) Data Aggregation
K Number
K082087Device Name
EYEFEEL OPHTHALMIC WARMER
Manufacturer
BIO-LIPID, INC.
Date Cleared
2008-09-11
(50 days)
Product Code
IMD
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
BIO-LIPID, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.
Device Description
The EyeFeel Warmer consists of a front layer, two oval shaped sacks that hold the iron powder mixture, and a back inner layer that is placed on the face. The iron powder mixture consists of iron powder, sodium chloride, filtrated water, powdered activated carbon, granular activated carbon, sodium polyacrylate powder, and exfoliated vermiculite.
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K Number
K021843Device Name
EYEFEEL OPHTHALMIC WARMER
Manufacturer
BIO-LIPID, INC.
Date Cleared
2002-09-03
(90 days)
Product Code
IMD
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
BIO-LIPID, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EyeFeel™ Ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
Device Description
The EyeFeel Ophthalmic Warmer is a simple device for application of heat therapy to the eye. It is shaped as a kind of "mask" to fit over the eyes, and consists of layers of synthetic paper, which surround a "sac" containing an iron powder mixture. Oxidation of the iron powder mixture generates heat.
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