← Product Code [FRA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA) · K232645 # Airgle Room Air Purifier (K232645) _Airgle Corporation · FRA · Feb 16, 2024 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K232645 ## Device Facts - **Applicant:** Airgle Corporation - **Product Code:** [FRA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA.md) - **Decision Date:** Feb 16, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6500 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for 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 Story Free-standing air purifier; utilizes internal fan to draw room air through rear grill; air passes through carbon filter and cHEPA filter (captures particles >0.3 microns); air then passes through Titanium Pro UV-C module (254nm) to inactivate viral organisms; purified air returned to room via front grill. Used in medical facilities and occupied spaces; operated by staff or patients. Output is purified air; device reduces viral load in indoor environments. Benefits patient by reducing airborne pathogen exposure. ## Clinical Evidence No clinical data. Bench testing only. MS2 bacteriophage log reduction >4.0 logs at 120 minutes (Models AG300/600/900). Filter efficiency 99.3% for 0.3-10um particles per ANSI/ASHRAE 52.2. ## Technological Characteristics Free-standing unit; Carbon filter; cHEPA filter; Titanium Pro UV-C module (254nm low-pressure mercury vapor quartz tube). 5 fan speeds. Ozone emission <0.050 ppm (UL 867). Electrical safety: IEC 60601-1, AAMI TIR69:2017, ANSI C63.27-2017. EMC: IEC 60601-1-2. ## Regulatory Identification A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. ## Predicate Devices - Molekule Air Mini ([K202339](/device/K202339.md)) ## Reference Devices - Bluezone Model RX-450 Air Purifier ([K212824](/device/K212824.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 16, 2024 Airgle Corporation Jet Li Regulation manager 1170 Lincoln Avenue Unit 2 Holbrook, New York 11741 Re: K232645 Trade/Device Name: Airgle Room Air Purifier Regulation Number: 21 CFR 880.6500 Regulation Name: Medical Ultraviolet Air Purifier Regulatory Class: Class II Product Code: FRA Dated: January 16, 2024 Received: January 16, 2024 Dear Jet Li: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely. Christopher K. Dugard -S Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical {2}------------------------------------------------ and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232645 Device Name Airgle Room Air Purifier Indications for Use (Describe) 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 | Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED {4}------------------------------------------------ {5}------------------------------------------------ # K232645 # 510(k) Summary This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. This is a Traditional 510(K) submission, and there were no prior submissions for the subject device. #### Date of the summary prepared: February 15, 2024 ## 1. Submitter's Information #### Sponsor - ♦ Applicant: Airgle Corporation - ♦ Address: 1170 Lincoln Avenue Unit 2 Holbrook, NY 11741 USA - Manufacturer: Shenzhen Airgle Corporation Limited � - ♦ Factory address: Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park, Houting Mao zhoushan Industrial Park, ShaJing Street, Baoan District, Shenzhen Guangdong, CN 518000 - ◆ Phone: +86-755-86726696 - ♦ Email: jerry@airgle.com.cn - ◆ Contact Person (including title): Jerry Liu (CTO) # Application Correspondent: - ◆ . Airgle Corporation - ♦ Address: 1170 Lincoln Avenue Unit 2 Holbrook, NY 11741 USA - ♦ Contact Person: Mr. Jet Li - ♦ Title: Regulation Manager - ♦ Tel: +86-18588874857 - ♦ Email: jianda-lee@foxmail.com {6}------------------------------------------------ #### 2. Subject Device Information - Type of 510(k) submission: Traditional � - � Classification: Medical Ultraviolet Air Purifier - � Trade Name: Airgle Room Air Purifier - � Model: AG300 /AG600 /AG900 - � Review Panel: General Hospital - � Product Code: FRA - � Regulation Number: 21 CFR 880.6500 - � Regulation Class: 2 # 3. Predicate / Reference Device Information | | Predicate Device | Reference Device | |-------------------|----------------------------------|------------------------------------| | 510(k) number | K202339 | K212824 | | Sponsor | Molekule, Inc. | Bluezone Products, Inc. | | Classification | Medical Ultraviolet Air Purifier | Medical Ultraviolet Air Purifier | | Trade Name | Molekule Air Mini | Bluezone Model RX-450 Air Purifier | | Review Panel | General Hospital | General Hospital | | Product Code | FRA | FRA | | Regulation Number | 21 CFR 880.6500 | 21 CFR 880.6500 | | Regulation Class | 2 | 2 | #### 4. 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. {7}------------------------------------------------ - The process begins when air moves through the Carbon filter, which captures the 2) 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. - Then the air moves through the Titanium Pro® module, where viral organisms are 4) inactivated by UV-C light. - Purified air is then returned to the room via the front grill. 5) ## 5. Intended Use / Indications for Use (For models: AG300/AG600/AG900) 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 the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions: | Test Item(s) | Test Results (Average Maximum Log Reduction /
Entrainment Time at Fan Speed 5) | |---------------|-----------------------------------------------------------------------------------| | MS2 | Model AG300: >4.0 Logs / 120 minutes | | Bacteriophage | Model AG600: >4.0 Logs / 120 minutes
Model AG900: >4.0 Logs / 120 minutes | # 6. Comparison to predicate device and conclusion The technological characteristics, features, specifications, materials, and intended use of Airgle Room Air Purifier are shown below in tabular form. {8}------------------------------------------------ | Device | Proposed Device | Primary Predicate
Device 1 | Reference Device 1 | Comment | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | | | K202339 | K212824 | | | Manufacturer | Airgle Corporation | Molekule, Inc. | Bluezone Products, Inc. | None | | Product Name | Airgle Room Air
Purifier
AG300/AG600/AG900 | Molekule Air Mini, | Bluezone Model RX-450
Air Purifier | None | | Device type | Medical Ultraviolet Air
Purifier | Purifier, Air, Ultraviolet,
Medical | Medical Ultraviolet Air
Purifier | Same | | Classification | Class II, FRA (21
CFR880.6500) | Class II, FRA (21
CFR880.6500) | Class II, FRA (21
CFR880.6500) | Same | | Use type | OTC | OTC | OTC | Same | | Intended Use | Destroy bacteria and
viruses by exposure to
ultraviolet radiation. | Destroy bacteria and
viruses by exposure to
ultraviolet radiation. | Kill bacteria and virus in
the air | Same | | Indications for use | The Airgle Room Air
Purifier is a free
standing, air purifying
device utilizing
germicidal ultraviolet
light 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 the following
MS2 bacteriophage
bioaerosol entrained
on the filter of the
subject device under
the following
exposure/working
conditions: | The Molekule Air Mini air
purifier is a device
intended for medical
purposes that is used
to capture 95% of
particulate matter and
destroy bacteria and
viruses by exposure to
ultraviolet radiation.

The Molekule Air Mini air
purifier has been
demonstrated to destroy
the following MS2
bacteriophage
bioaerosol entrained on
the filter of the subject
device under the
following
exposure/working
conditions: | 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: | Subject and Predicate
Devices tested against the
same organism

Reference Device tested
against additional
organisms | {9}------------------------------------------------ {10}------------------------------------------------ | Test Item(s) | Test Results (Average Maximum Log Reduction / Entrainment Time at Fan Speed 5) | |------------------------------|----------------------------------------------------------------------------------------------------------------------| | MS2 Bacteriophage | Model AG300: >4.0 Logs / 120 minutes
Model AG600: >4.0 Logs / 120 minutes
Model AG900: >4.0 Logs / 120 minutes | | Test Item | Test Result | | Virus | MS2 bacteriophage
$5.09\pm0.42$ / 120 mins | | Particulate matter | 0.3 to 1.0 micron size particles
95% or greater according to ASHRAE 52.2 | | Test item | Average Net Log Reduction/Time @ High Fan Speed. Room Temperature Test | | Bact Bacillus atrophaeus | 4.95 / 60 minutes | | Bact 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 | {11}------------------------------------------------ {12}------------------------------------------------ | Device | Proposed Device | Primary Predicate
Device 1
K202339 | Reference Device 1
K212824 | Comment | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Mechanism of Action | UV-C inactivation of
microorganisms | UV light of sufficient
energy (UV-A) activates
photocatalyst that
destroys
microorganisms
entrained on the filter
through a hotochemical
reaction. | UV-C inactivation of
microorganisms | Subject, Predicate and
Reference Devices all
reduce viable and no-viable
aerosols by entrainment
onto filter media and
biocidal action of UV Light | | Installation | Free standing | Free standing | Free standing | Same | | Elements of design | Fan circulates air
through a shielded
chamber where UV
light irradiates
microbial aerosols | Fan circulates air
through a shielded
chamber where UV light
irradiates microbial
aerosols | Fan circulates air
through a shielded
chamber where UV light
irradiates microbial
aerosols | Same | | Filter | Yes | Yes | Yes | Same | | Filtration type | Particle filter | Particle filter | Particle filter | Same | | Device | Proposed Device | Primary Predicate
Device 1
K202339 | Reference Device 1
K212824 | Comment | | Internal Fan | Yes | Yes | Yes | Same | | Fan speed | 5 speeds | 5 Speeds | 2 Speeds | No new safety or efficacy
questions raised by
differences. Any
performance differences
mitiagted by test results | | Germicidal UV | Yes | Yes | Yes | Same | | UV Optic type | Quartz tube with low
pressure mercury
vapor | UV Light Source:
LED | Quartz tube with low
pressure mercury vapor | No new safety or efficacy
questions raised by
differences. Any
performance differences
mitiagted by test results. | | UV wavelength | 254nm | 320-400 nm | 254nm | No new safety or efficacy
questions raised by
differences. Any | | Device | Proposed Device | Primary Predicate
Device 1
K202339 | Reference Device 1
K212824 | Comment | | | | | | performance differences
mitigated by test results. | | Ozone Emission | Does not exceed a
concentration of 0.050
ppm according to UL
867 | Does not exceed a
concentration of 0.050
ppm according to UL
867 | Does not exceed a
concentration of 0.050
ppm according to UL
867 | Same | | Removal of bacterial
spores | Not claimed | Not claimed | 99.99% | No new safety or efficacy
questions raised by
differences. Performance
differences mitigated by
labeling claims. | | Removal of mold
spores | Not claimed | Not claimed | 99.99% | No new safety or efficacy
questions raised by
differences. Performance
differences mitigated by
labeling claims | | Device | Proposed Device | Primary Predicate
Device 1
K202339 | Reference Device 1
K212824 | Comment | | Removal of
Aerosolized MS2
Bacteriophage | 4.0 net LOG reduction
in a 30 m3 space at
120 minutes | 4 log reduction
(99.99%) | 4.0 net LOG reduction in
a 16m3 space at 35
minutes. | No new safety or efficacy
questions raised by
differences. Performance
differences mitigated by
labeling claims | | UV radiance and
leakage in occupied
spaces | None | None | Effective irradiance <0.1
uW/cm2 | Same | | Chemical Additives | No | No | No | Same | | Electrical safety | IEC 60601-1
AAMI TIR69:2017
ANSI C63.27-2017 | UL 507 | UL 507 | No new safety or efficacy
questions raised by
differences in Standards
applied. | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same | {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ {16}------------------------------------------------ ## 7. Summary for non-clinical test The non-clinical testing was provided to demonstrate the subject device met the acceptance criteria of the test methodology or standards listed below. Airgle Room Air Purifier complies with voluntary standards for electrical safety and electromagnetic compatibility. | Name of test
methodology | Purpose | Acceptance Criteria | Results | |-------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------|---------| | IEC 60601-1
IEC 60601-1-2 | Demonstration of basic safety and essential performance | Meets criteria for CISPR Group 1A | PASS | | AAMI TIR69:2017
ANSI C63.27-2017 | wireless coexistence test | Wireless System ability to coexist with interfering networks in the 2.4G band. | PASS | | Bacteriophage Test | Demonstration of log reduction of viral load | At least 99.99% reduction of MS2 bacteriophage after 2 hours | PASS | | ANSI/ASHRAE
Standard 52.2 | Demonstration of filter efficiency | At least 99.3% for 0.3-10 um | PASS | | Software validation | Demonstration of software security and good design | Meets design criteria | PASS | #### 8. Summary for clinical test Not applicable # 9. Conclusion The Conclusion drawn from the non-clinical testing demonstrates that the subject device, Airgle Room Air Purifier, is as safe, as effective, and performs as well for the documented intended use as the legally marketed predicate device cleared under K202339 and the reference device cleared under K212824. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K232645](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K232645) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com