KnoxFog Anti-fogging Device

K251068 · Uv One Hygienics, Inc. · OCT · Aug 27, 2025 · Gastroenterology, Urology

Device Facts

• Record ID: K251068
• Device Name: KnoxFog Anti-fogging Device
• Applicant: Uv One Hygienics, Inc.
• Product Code: OCT · Gastroenterology, Urology
• Decision Date: Aug 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The KnoxFog™ Anti-fogging Device is a temporary anti-fog coating and therein inhibits fogging on optical lenses. It is a laparoscopic accessory intended to facilitate intraoperative defogging of laparoscope lenses, thereby maintaining visualization of the surgical site and closed body cavity.

Device Story

KnoxFog is a semi-solid gel anti-fog coating; supplied in single-use containers; terminally sterilized via gamma radiation. Applied to rigid endoscope lenses immediately prior to surgery; transforms into a solid-phase hydrophilic film. Prevents condensation on lenses in high-humidity, temperature-variable surgical environments. Used by surgeons/clinical staff in OR settings to maintain visualization of surgical sites and closed body cavities. Benefits patient by ensuring continuous optical clarity during laparoscopic procedures, reducing need for lens removal/cleaning.

Clinical Evidence

Bench testing only. Comparative study (n=not specified) showed KnoxFog-treated lenses remained fog-free for 71.6 ± 3 minutes vs 62 ± 5.5 minutes for predicate. Additional testing included simulated transportation, six-month accelerated aging, and ISO 10993 biocompatibility assessment.

Technological Characteristics

Semi-solid gel formulation; hydrophilic surface chemistry. Single-use container. Terminally sterilized via gamma radiation. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as an anti-fog solution applied to rigid endoscope lenses prior to insertion into the body to maintain optical clarity during endoscopic procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• VitreOx™ (K163257)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 27, 2025

UV One Hygienics, Inc.
Dora Suppes
CEO
Banner Desert Hospital Medical Campus
1432 S. Dobson Road, Ste. 202
Mesa, Arizona 85202

Re: K251068
Trade/Device Name: KnoxFog Anti-fogging Device
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: OCT
Dated: March 17, 2025
Received: April 7, 2025

Dear Dora Suppes:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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" (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 QS 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin K. Chen
-5
Digitally signed by Colin K. Chen
Date: 2025.08.27 14:51:31
-04'00"

Colin Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251068 | |
| Device Name KnoxFog Anti-fogging Device | |
| Indications for Use (Describe) The KnoxFog™ Anti-fogging Device is a temporary anti-fog coating and therein inhibits fogging on optical lenses. It is a laparoscopic accessory intended to facilitate intraoperative defogging of laparoscope lenses, thereby maintaining visualization of the surgical site and closed body cavity. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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KnoxFog™ Device Anti-Fog Gel

UONE HYGIENICS

March 12, 2025 12:48 PM

| DEVICE SUMMARY | | |
| --- | --- | --- |
| Document Title | Document Description | Version No. |
| KF-25-KFDS | KnoxFog™ Device Summary | Final |

# 510(k) SUMMARY

## Submitter Information

- Name: UV ONE Hygienics, Inc.
- Address: 1432 S. Dobson Rd. Ste. 202, Mesa, AZ 85202
- Contact Person: Dora Suppes, CEO
- Phone: [phone]
- Email: [e-mail]/[e-mail]
- Date Prepared: March 12, 2025

## Device Information

- Trade Name: KnoxFog™
- Common Name: Anti-fog solution for endoscopic lenses
- Classification Name: Endoscope and accessories (21 CFR 876.1500)
- Regulatory Class: Class II
- Product Code: OCT (Anti-Fog Solution and Accessories, Endoscopy)

## Predicate Device

VitreOx™ (K163257)

## Device Description

KnoxFog™ is a semi-sol gel anti-fog coating designed to prevent condensation on endoscopic lenses during surgical procedures. The device is supplied as a sterile solution in single-use containers for application immediately prior to endoscopic procedures. When applied to the endoscope lens, KnoxFog™ forms a transparent hydrophilic coating that prevents fog formation by maintaining optical clarity in high-humidity environments. The product is terminally sterilized using gamma radiation to ensure safety for use in surgical environments.

## Indications for Use

KnoxFog™ is intended for use as an anti-fog solution applied to rigid endoscope lenses prior to insertion into the body to maintain optical clarity during endoscopic procedures.

© 2025 UV ONE Hygienics, Inc., Infinitum BioMed, Inc. All rights reserved. Confidential information. This document contains proprietary information and trade secrets of UV ONE Hygienics, Inc., Infinitum BioMed, Inc. Any unauthorized copying, use, distribution, or disclosure of this document or any portion thereof is strictly prohibited. This document is provided under confidential disclosure agreement and may not be reproduced, shared, or distributed without prior written consent from UV ONE Hygienics, Inc., Infinitum BioMed, Inc.

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KnoxFog™ Service Arch-Fog Gen

UONE HYGIENICS

March 12, 2025 12:48 PM

| DEVICE SUMMARY | | |
| --- | --- | --- |
| Document Title | Document Description | Version No. |
| KF-25-KFDS | KnoxFog™ Device Summary | Final |

# Technological Characteristics

KnoxFog™ utilizes a semi-sol gel formulation that transforms into a solid-phase film upon application to the endoscope lens. This creates a hydrophilic surface that prevents water condensation (fogging) when the lens encounters temperature differentials and humid environments typical of endoscopic procedures.

# Performance Data

Bench testing was conducted to establish substantial equivalence to the predicate device. Testing included:

1. Time-to-Fog Analysis: Comparative testing demonstrated that $\mathrm{KnoxFog}^{\mathrm{TM}}$ -treated endoscope lenses remained fog-free for an average of $71.6 \pm 3$ minutes compared to $62 \pm 5.5$ minutes for $\mathrm{VitreOx}^{\mathrm{TM}}$ -treated lenses, representing $117\%$ relative performance compared to the predicate device.
2. Transportation Testing: Simulated shipping and handling testing verified product stability under various transportation conditions.
3. Accelerated Aging: Six-month accelerated aging studies confirmed product shelf-life claims.
4. Biocompatibility Testing: Testing in accordance with ISO 10993 standards demonstrated that $\mathrm{KnoxFog}^{\mathrm{TM}}$ is biocompatible for its intended use, with comprehensive assessment addressing previous cytotoxicity concerns.

# Conclusion

Based on the comparative performance testing and technological characteristics, $\mathrm{KnoxFog}^{\mathrm{TM}}$ is substantially equivalent to the legally marketed predicate device, $\mathrm{VitreOx}^{\mathrm{TM}}$ (K163257). Testing demonstrates that $\mathrm{KnoxFog}^{\mathrm{TM}}$ performs as intended and does not raise new questions of safety or effectiveness.

© 2025 UV ONE Hygienics, Inc., Infinitum BioMed, Inc. All rights reserved. Confidential information. This document contains proprietary information and trade secrets of UV ONE Hygienics, Inc., Infinitum BioMed, Inc. Any unauthorized copying, use, distribution, or disclosure of this document or any portion thereof is strictly prohibited. This document is provided under confidential disclosure agreement and may not be reproduced, shared, or distributed without prior written consent from UV ONE Hygienics, Inc., Infinitum BioMed, Inc.