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Found 5 results
510(k) Data Aggregation
K Number
K143351Device Name
iCase Contact Lens Case
Manufacturer
Novabay Pharmaceuticals, Inc
Date Cleared
2015-04-29
(156 days)
Product Code
LRX
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
Novabay Pharmaceuticals, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.
Device Description
The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement.
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K Number
K131542Device Name
NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
Manufacturer
Novabay Pharmaceuticals, Inc
Date Cleared
2013-07-24
(56 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Novabay Pharmaceuticals, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Device Description
NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid solution cleanser and wound dressing that was previously cleared by FDA for Rx Use only. The device for OTC use is exactly the same as the Rx product. It is composed of hypochlorous acid (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits growth of microorganisms in solution. The cleanser is provided in a glass bottle; a pump attachment for use in spraying the cleanser on wounds is also provided.
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K Number
K113820Device Name
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
Manufacturer
NOVABAY PHARMACEUTICALS
Date Cleared
2012-08-08
(225 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOVABAY PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NeutroPhase Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material including microorganisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
Device Description
NeutroPhase Skin and Wound Cleanser is a clear, liquid solution cleanser and wound dressing that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the skin and wound cleanser moving across the wound bed. The product is composed of HOCl 0.01% in saline. The antimicrobial agent inhibits the growth of microorganisms in solution.
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K Number
K081009Device Name
NEUTROPHASE
Manufacturer
NOVABAY PHARMACEUTICALS
Date Cleared
2008-05-20
(42 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
NOVABAY PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
Device Description
NeutroPhase is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The device is offered in various bottle sizes.
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K Number
K071056Device Name
NEUTROPHASE WOUND CLEANSER
Manufacturer
NOVABAY PHARMACEUTICALS
Date Cleared
2007-09-28
(165 days)
Product Code
FRO, KMF
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
NOVABAY PHARMACEUTICALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
Device Description
NeutroPhase™ is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris.
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