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K Number
K241140Device 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
880.6500Why did this record match?
Applicant Name (Manufacturer) :
Applied Photonix, LLC
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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