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510(k) Data Aggregation

    K Number
    K241140
    Device Name
    ViroZap Indoor Air Purifier, In Duct Model 1008
    Manufacturer
    Applied Photonix, LLC
    Date Cleared
    2024-08-01

    (99 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a device intended for medical purposes that is used to destroy microorganisms entrained on the filter through a photochemical reaction in the air by exposure to UV-A radiation. The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2 - a non-enveloped ssRNA virus, Phi-X174 - a non-enveloped ssDNA virus, Aspergillus brasiliensis mold spores, and Bacillus subtilis endospores entrained on the filter under the following exposure conditions: | Organism | Name | Average Maximum Log Reduction / Exposure Time<br>(hours) by Temperature | | | |------------------------|-------------------------------|-------------------------------------------------------------------------|------------------|------------------| | | | 45°F | 72°F | 110°F | | Bacteria | Staphylococcus<br>epidermidis | 4.94 / 12 hours | 4.54 / 4 hours | 4.51 / 4 hours | | Bacteria | Klebsiella aerogenes | 5.40 / 1 hour | 6.55 / 1 hour | 6.54 / 1 hour | | Virus | MS2 bacteriophage | 4.32 / 12 hours | 4.51 / 4 hours | 4.58 / 4 hours | | Virus | Phi-X174 bacteriophage | 4.39 / 12 hours | 5.24 / 4 hours | 5.14 / 4 hours | | Mold endospore | Aspergillus brasiliensis | 4.52 / 168 hours | 5.61 / 168 hours | 5.61 / 168 hours | | Bacterial<br>endospore | Bacillus Subtilis | 4.83 / 168 hours | 4.21 / 168 hours | 4.34 / 168 hours | The ViroZap™ Indoor Air Purifier, In Duct Model 1008 has been demonstrated to destroy Staphylococcus epidermidis, Klebsiella aerogenes, MS2, Phi-X174, Aspergillus brasiliensis, and Bacillus subtilis in a large chamber (9.1 ft x 9.1 ft x 7 ft) at a flow rate of 500 cfm (cubic feet per minute): | Organism | Name | Average Net Log Reduction<br>in 20 Minutes | |---------------------|----------------------------|--------------------------------------------| | Bacteria | Staphylococcus epidermidis | 5.17 | | Bacteria | Klebsiella aerogenes | 5.56 | | Virus | MS2 bacteriophage | 5.00 | | Virus | Phi-X174 bacteriophage | 5.34 | | Mold endospore | Aspergillus brasiliensis | 4.50 | | Bacterial endospore | Bacillus Subtilis | 4.58 |
    Device Description
    The ViroZap™ Indoor Air Purifier, In Duct Model 1008 is a medical ultraviolet air purifier, which incorporates patented photo-electrochemical or photo-electrocatalyst (PEC) ultraviolet air purification technology that destroys bacteria in air in medical facilities. It consists of a pre-fiter, UV-A lamps, and a catalytic filter coated with a photocatalyst. The ViroZap™ has metal housing with electronic controls, and it is installed in the ducts of a building's HVAC system. It will be available in two sizes: one size with outer dimensions of 28.5 inches by 12.25 inches, and a second size with outer dimensions of 24 inches by 12.25 inches. The ViroZap 110 device has a pre-filter and a chamber equipped with 6 low energy ultraviolet LED lights (UV-A), which emit light with wavelengths between 320-400 nm, and a catalytic filter.
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    K Number
    K232642
    Device Name
    AirKEE T900
    Manufacturer
    HealKEE Medical Pte Ltd
    Date Cleared
    2024-05-23

    (267 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation. AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions: Test Item | Avg. max Log Reduction/Entrainment Time (min) Room Temperature Test -----------|------------------------------------------------------------------------------------------------------------------ Bacteria | Staphylococcus albus Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed Bacteria | Escherichia coli Log 4 (99.99%)/60 minutes @ high fan speed Log 4 (99.99%)/120 minutes @ low fan speed Mold | Penicillium rocqueforti Log 4 (99.99%)/60 minutes @ high fan speed Mold | Aspergillus Niger Log 4 (99.99%)/120 minutes @ low fan speed Virus | Influenza A virus, H1N1 Log 4 (99.99%)/60 minutes @ high fan speed Virus | Influenza A virus, H3N2 Log 4 (99.99%)/120 minutes @ low fan speed
    Device Description
    AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine. AirKEE T900's main components consist of: Multi-stage air treatment - a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter - UV lamps that generate UV-C irradiation to eliminate microorganisms о - o a motor/impeller to move air through the filtration system System control - o an electronic control system to power and control the device - a touch panel interface to indicate the working status of the device and consumables O AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine. The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
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    K Number
    K232933
    Device Name
    AirKEE P900
    Manufacturer
    HealKEE Medical Pte Ltd
    Date Cleared
    2024-05-16

    (239 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AirKEE P900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacteria, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation. AirKEE P900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions: Test Item | Avg. max Log Reduction/Entrainment Time (min) (in a 20m3 chamber) ---|--- Bacteria Staphylococcus aureus | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Escherichia coli | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Klebsiella pneumoniae | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Pseudomonas aeruginosa | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Bacteria Serratia marcescens | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Mold<br>Aspergillus Niger | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Virus<br>Influenza A virus, H1N1 | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed Virus<br>Influenza A virus, H3N3 | Log 4 (99.99%)/60 minutes @ high fan speed<br>Log 4 (99.99%)/120 minutes @ low fan speed
    Device Description
    AirKEE P900 is a mobile multi-function medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE P900 is controlled via a touchscreen control panel on the machine. AirKEE P900's main components consist of: Multi-stage air treatment - a filtration system with primary filter, HEPA filter, activated carbon filter, and nano- O material filter - UV lamps that generate UV-C irradiation to inactivate and eliminate microorganisms o - a motor/impeller to move air through the filtration system o System control - o a touch panel interface to indicate the working status of the device and consumables AirKEE P900's multi-stage air treatment: Air enters through the bottommost chamber and fans direct the air in an upwards manner. Firstly, air passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Air then passes through activated carbon filter. Lastly, HEPA H13 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top in an upwards manner. The control panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.
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    K Number
    K232645
    Device Name
    Airgle Room Air Purifier
    Manufacturer
    Airgle Corporation
    Date Cleared
    2024-02-16

    (170 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Airgle Room Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria and virus in medical facilities and occupied spaces. The Airgle® Air Purifier has been demonstrated to destroy MS2 bacteriophage bioaerosol entrained on the filter of the subject device in the following exposure/working conditions: | Test Item(s) | Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) | |-------------------|--------------------------------------------------------------------------------| | MS2 Bacteriophage | Model AG300: >4.0 Logs / 120 minutes | | MS2 Bacteriophage | Model AG600: >4.0 Logs / 120 minutes | | MS2 Bacteriophage | Model AG900: >4.0 Logs / 120 minutes |
    Device Description
    Airgle Room Air Purificr is an air purification device that employs an ultraviolet air purification technology to inactivate viral aerosols. It is a free-standing device, which has a sealed main housing including a Carbon filter, a cHEPA filter and Titanium Pro (UV-C) module. Model AG300 use a 2-in-1 filter which combine the Carbon filter and cHEPA filter. The operation of the device is as follows: 1) Room air is drawn into the device via the rear grill. 2) The process begins when air moves through the Carbon filter, which captures the large particles 3) Next, the air moves through the cHEPA filter, which captures a particle size greater than 0.3 microns. The filter is an ultra-high performance cHEPA filter, which filters respirable particulate matter with an efficiency reaching 99.3% at least. 4) Then the air moves through the Titanium Pro® module, where viral organisms are inactivated by UV-C light. 5) Purified air is then returned to the room via the front grill.
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    K Number
    K221540
    Device Name
    Synexis Sphere Rx
    Manufacturer
    Synexis, LLC
    Date Cleared
    2023-06-14

    (383 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synexis Sphere Rx is a stand-alone air purifier device intended for medical purposes and is used for the reduction of bacteria and viruses in the air. The device is intended for use in professional healthcare environments. The Sphere Rx is not intended for use near HF surgical equipment or MRI settings. The Synexis Sphere Rx air purifier demonstrated a ≥ 4 log reduction of bacteria and viruses under the following exposure/ working conditions: | Organism Type | Organism Name | Test Temp/RH | Avg Net Log Reduction/Time@ High Fan Speed | |----------------|----------------|-----------------------|--------------------------------------------| | Gram- bacteria | K. aerogenes | 25±3 deg C, 60 ±5% RH | 4.25 / 240m | | Gram+ bacteria | S. epidermidis | 25±3 deg C, 60 ±5% RH | 4.19 / 360m | | Virus | MS2 | 25±3 deg C, 60 ±5% RH | 4.55 / 300m | | Organism Type | Organism Name | Test Temp/RH | Avg Net Log Reduction/Time@ Low Fan Speed | | Gram- bacteria | K. aerogenes | 25±3 deg C, 60 ±5% RH | 4.25 / 240m | | Gram+ bacteria | S. epidermidis | 25±3 deg C, 60 ±5% RH | 4.13 / 480m | | Virus | MS2 | 25±3 deg C, 60 ±5% RH | 4.11 / 480m |
    Device Description
    The Synexis Sphere Rx is a photocatalytic air purifier that utilizes a photocatalytic oxidation purification process involving a light-activated catalyst which reacts with organic pollutants to oxidize them. The Sphere Rx draws ambient air through multiple filters including a carbon filter, a MERV filter and a photocatalytic filter that Synexis refers to as a 'Sail'. When the ambient air containing oxygen and water molecules contacts the photocatalytic filter exposed to UV light, a chemical reaction is initiated inside the device that generates hydroxyl radicals, super oxides and hydrogen peroxides. Synexis refers to the hydrogen peroxide molecules as dry hydrogen peroxide or DHP to distinguish these molecules from the aqueous form of hydrogen peroxide. The mechanism of action for the Sphere Rx photocatalytic air purifier to reduce microorganisms, including bacteria and viruses, in the air for small room environments relies on combination of capture and destruction. Ambient air is continuously circulated through MERV and carbon filters and a photocatalytic medium under UV light exposure inside the device to achieve a 4 log reduction.
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    K Number
    K222702
    Device Name
    RGS; RGS Mini
    Manufacturer
    Genesis Air, Inc.
    Date Cleared
    2023-06-02

    (268 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3. This device is not intended for use in areas with a sterile field or controlled air flow.
    Device Description
    The RGS / RGS mini is a medical ultraviolet air purifier that is intended for medical purposes. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. The device uses a MERV 13 filter for particle filtration. Down upstream of the pre-filter is a PCO component. The PCO consists of a TiO2 coated mesh and UV lights. When the UV lights (UV-C) provide sufficient energy, the TiO2 coated photo catalyst is activated. This component will deactivate microorganisms and viruses through a chemical reaction. The RGS / RGS mini model numbers RGS and RGS mini have demonstrated the ability to eliminate Staphylococcus Epidermidis, Bacteriophage MS2, and Escherichia Coli in the air of the test chamber in 60 minutes under the following conditions. The device with model number RGS and a high fan speed of 600 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.0 PFU/ft^3. The device with model number RGS and a high fan speed of 600 CFM when tested against Bacteriophage MS2 had a log reduction of 4.02 PFU/ft^3.The device with model number RGS and a high fan speed of 600 CFM when tested against Escherichia Coli had a log reduction of 4.24 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Staphylococcus Epidermidis (gram positive) had a log reduction of 4.04 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Bacteriophage MS2 had a log reduction of 4 PFU/ft^3. The device with model number RGS mini and a high fan speed of 500 CFM when tested against Escherichia Coli had a log reduction of 4.0 PFU/ft^3.
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    K Number
    K223328
    Device Name
    Purgo
    Manufacturer
    AeroClean Technologies, Inc.
    Date Cleared
    2022-11-30

    (30 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pūrgo™ is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo™ is non-sterile. Pūrgo™ has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Name | Avg. max log reduction / exposure<br>time (min) | |-----------------|-----------------------------------------------------|-------------------------------------------------| | Gram + Bacteria | Methicillin resistant Staphylococcus<br>epidermidis | 4.6 (45) at normal speed | | Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed | | Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed | | RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed | | RNA Virus | SARS-CoV-2 | 4.2 (60) at normal speed | | DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed | | Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
    Device Description
    Pūrgo™ is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo™ may be used in medical facilities and commercial home healthcare environments. Pūrgo™'s main components consist of: - LED UV-C lamps that generate irradiation to destroy microorganisms that are not . filtered; - . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material: - a filtration system with pre-filter, activated carbon filter, and HEPA filter; . - . a motor / impeller to move air through the filtration system; - . sensors to monitor UV irradiance and airflow: - . an electronic control system to power and control the device; and - . a touch panel interface equipped with LEDs to indicate the working status of the device. Pūrgo™ has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air. Pūrgo™ pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and funqi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm. Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce. After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.
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    K Number
    K213753
    Device Name
    Purgo
    Manufacturer
    AeroClean Technologies, LLC
    Date Cleared
    2022-06-01

    (183 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pūrgo is a combination UV and air filtration device, equipped with UV-C LEDs and a True HEPA filter intended for the reduction of bacteria, virus, fungal spores, and particles in air for use in medical facilities and other indoor spaces. Pūrgo is non-sterile. Pūrgo has been demonstrated to remove the following organisms under the following exposure conditions: | Organism | Name | Avg. max log reduction / exposure time (min) | |-----------------|-----------------------------------------------------|----------------------------------------------| | Gram + Bacteria | Methicillin resistant Staphylococcus<br>epidermidis | 4.6 (45) at normal speed | | Gram + Bacteria | Bacillus globigii endospore | 4.1 (60) at normal speed | | Gram - Bacteria | Escherichia coli | 5.4 (45) at normal speed | | RNA Virus | MS2 bacteriophage | 5.4 (60) at normal speed | | DNA Virus | Phi-X174 bacteriophage | 4.4 (45) at normal speed | | Fungal Spore | Aspergillus brasiliensis spore | 4.3 (90) at normal speed |
    Device Description
    Pūrgo is a free-standing air disinfection system employing two technologies for purifying air: HEPA filtration and UV-C light irradiation, removing or destroying bacteria and viruses in air. Pūrgo may be used in medical facilities and commercial home healthcare environments. Pūrgo's main components consist of - . LED UV-C lamps that generate irradiation to destroy microorganisms that are not filtered: - . a proprietary SteriDuct chamber that intensifies the UV-C light to destroy microbiological material: - . a filtration system with pre-filter, activated carbon filter, and HEPA filter; - . a motor/impeller to move air through the filtration system: - . sensors to monitor UV irradiance and airflow; - . an electronic control system to power and control the device; and - . a touch panel interface equipped with LEDs to indicate the working status of the device. Pūrgo has several built-in safety features that will prevent operation of the filter cartridge is not in place or if the filter door is not closed. The unit also incorporates UV and airflow sensors that provide warnings to the user if the device is not performing as designed to purify air. Pūrgo pulls air through a filter cartridge and then passes the filtered air through a chamber containing UV-C light to neutralize remaining airborne microorganisms (such as bacteria, viruses, and fungi). The filter cartridge contains a series of three filters, the first of which is a pre-filter that removes physically large particulate matter (such as dust) and protects the finer particle filters downstream. This is followed by an Activated Carbon filter. Finally, a HEPA (highefficiency particulate air) filter that removes 99.995% of the remaining airborne particles above a particle size of 0.1 µm. Any microbes that still manage to make it through the filters, pass through the SteriDuct chamber where they are subjected to Ultraviolet Radiation at 265 nm (UV-C). UV radiation at this wavelength is particularly effective at destroying microbes. UV-C irradiation has been shown to damage the microbe's RNA and DNA genetic materials sufficiently to prevent the microbe's ability to reproduce. After passing through the filtration and SteriDuct UV-C chamber, the purified air then exits back into the room. The exit air does not destroy laminar air flow in a typical operating room environment.
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    K Number
    K212644
    Device Name
    Aura Storm
    Manufacturer
    Invictus Lighting
    Date Cleared
    2022-05-26

    (279 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aura Storm air purifier is a device intended for medical purposes that is used to capture and destroy bacteria and viruses in the air through the multi-stage filtration system and exposure to ultraviolet radiation. The Aura Storm air purifier has been demonstrated to destroy the following bacteria: Staphylococcus albicans, Staphylococcus aureus, and Escherichia Coli, and virus: A/PR8/34 HIN1 virus entrained on the filter of the subject device under the following exposure conditions: Average Maximum log reduction / entrainment time (minutes) at Fan Speed 4. Room Temperature test: Log 4 (99.99%) / 60 minutes. Average Maximum log reduction / entrainment time (minutes) at Fan Speed 1. Room Temperature test: Log 4 (99.99%) / 120 minutes.
    Device Description
    The Aura Storm is a multi-stage UV-C air purifier that delivers air purification for rooms up to 2700 square feet (*52ft x 52ft). The Storm inactivates and eliminates bacteria and viruses in the Aura Storm may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. The Aura Storm is a standalone device that is controlled via buttons on the top of the unit. The Aura Storm is a dual-sided system with each side consisting of four-stage is a prefilter. The second stage is a HEPA H13+ filter. The third stage is a TiO2 cold photo-catalyst filter. Finally, the UV-C sterilization lamp emits a 253.7mm designed to activate the photo-catalyst filter and eliminate bacteria and viruses. The anion generator is used strictly to increase the size of the particulate molecules to increase the ability to capture and eliminate the bacteria and viruses. This designed system delivers a third-party tested 99.99% (4-log) sterilization in 60 minutes at the highest fan speed. The Aura storm was also tested at the lowest fan speed and delivered a 99.99% (4-log) sterilization in 120 minutes. The air flow diagram has been submitted in the 510(k) submission. There is an internal fan which draws in air from both sides of the unit, filters it through the multi-stage system and outputs the filtered air through the top of the unit features a capacitive touch button control to operate the On/Off, fan speed (4 speeds), Auto mode, UV lamp, Anion generator, Child lock, timer, and filter reset. There is also a particulate matter sensor and color bar to indicate the level of clean air.
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    K Number
    K212824
    Device Name
    Bluezone Model RX-450 Air Purifier
    Manufacturer
    Bluezone Products, Inc.
    Date Cleared
    2022-02-17

    (167 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Product Code :

    FRA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bluezone Model RX-450 Air Purifier is a free standing, air purifying device utilizing germicidal ultraviolet light (UV-C wavelengths near 254nm) intended for inactivation of indoor airborne aerosols including bacteria, mold, and virus in medical facilities and occupied spaces. The Bluezone Model Rx-450 Air Purifier has been demonstrated to entrain and destroy the following exposure/working conditions: | Test Item | Average Net Log Reduction/Time @ High Fan<br>Speed. Room Temperature Test | | |-----------|---------------------------------------------------------------------------|-------------------| | Bacteria | Bacillus atrophaeus | 4.95 / 60 minutes | | Bacteria | Bacillus atrophaeus | 4.00 / 48 minutes | | Mold | Penicillium rocqueforti | 4.40 / 60 minutes | | Mold | Penicillium rocqueforti | 4.00 / 52 minutes | | Virus | MS-2 bacteriophage | 5.32 / 60 minutes | | Virus | MS-2 bacteriophage | 4.00 / 40 minutes |
    Device Description
    The Bluezone Model RX-450 is an air purification device that uses germicidal UV bulbs to inactivate viral, bacterial or fungal aerosols. The operation of the device is as follows: ambient air containing microbial aerosols is drawn into the air purifier through a prefilter and two angled aluminum honeycomb light baffles. The infective aerosols in the air are then exposed to high intensity, germicidal, ultraviolet light where the contaminants receive a UV dose of at least 10 mW*second/cm². The bacterial, fungal and viral aerosols are inactivated through the breakdown of the microbial DNA or RNA. The cleaned air is exhausted back into the room from the Bluezone Model RX-450 through an axial fan.
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