Who is the manufacturer of LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)?

Light Tree Ventures Europe B.V. filed the 510(k) submission for LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (K221775).

What is the FDA product code for LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)?

OHS. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)?

Shani Darden LED light therapy mask (K214103); FaceLITE (K191629).

Who can help prepare an FDA 510(k) submission like LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)

K221775 · Light Tree Ventures Europe B.V. · OHS · Dec 20, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221775
Device Name	LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
Applicant	Light Tree Ventures Europe B.V.
Product Code	OHS · General, Plastic Surgery
Decision Date	Dec 20, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

Device Story

Home-use wearable LED phototherapy mask; flexible silicone construction with integrated LEDs and controller. Inputs: user-selected treatment mode via controller. Operation: emits specific wavelengths (Blue 415nm, Red 630nm, NIR 830nm) to skin surface; controller manages treatment duration (10 minutes) and mode switching. Output: light energy for acne treatment or wrinkle reduction. Used by patients at home; no clinical supervision required. Device does not perform measurements or diagnostic conclusions. Benefits: non-invasive treatment for acne and facial wrinkles. Powered by rechargeable lithium battery; non-operational during charging. Includes removable eye protection for specific models.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), photobiological safety (IEC 62471), biocompatibility (ISO 10993), and usability testing (IEC 62366-1).

Technological Characteristics

Flexible silicone mask; rechargeable lithium battery; LED light source (Blue 415nm, Red 630nm, NIR 830nm). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, ISO 10993. Software-controlled timer for 10-minute treatment duration. No connectivity/cloud features.

Indications for Use

Indicated for treatment of full-face wrinkles (all models) and mild to moderate acne vulgaris of the face (models MK66-H, EL00003) in over-the-counter, home-use settings.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

Shani Darden LED light therapy mask (K214103)
FaceLITE (K191629)

Related Devices

K242593 — CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Feb 14, 2025
K242068 — LED Light Therapy Mask (RT01) · Ningbo Dechang Electrical Machinery Made Co.,Ltd · Apr 4, 2025
K213184 — MZ Skin LightMAX Supercharged LED Mask 2.0 · Mz Skin · Nov 23, 2021
K254079 — LED Light Therapy Mask (Models: T2, RLD10) · Shenzhen Desida Technology Co., Ltd. · Mar 16, 2026
K251667 — LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) · Shenzhen Liyoutong Technology Co., Ltd. · Aug 7, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 20, 2022 Light Tree Ventures Europe B.V. % Alain Dijkstra Official Correspondent Shenzhen Kaiyan Medical Equipment Co., Ltd Building 3, No. 40, Fuxin street, Huaide Community Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China Re: K221775 Trade/Device Name: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, EL00003) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, OLP Dated: October 21, 2022 Received: October 21, 2022 Dear Alain Dijkstra: 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 (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 located 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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. # Jianting Wang -S Jianting Wang 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221775 Device Name LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003) # Indications for Use (Describe) For MK-78, MK-04, The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. #### For MK66-H, EL00003 The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the treatment of full-face wrinkles. | 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. 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 510(k) Summary for K221775 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ## 1. Submitter's Information Sponsor Name: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com ## Manufacturer: Manufacturer Name: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Contact Person (including title): Alain Dijkstra (CEO) Tel: 0755-82129361 Fax: 0755-25024651 E-mail: alaindijkstra@kaiyanmedical.com ## Application Correspondent: Contact Person: Alain Dijkstra Company: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Address: Building 3, No.40, Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com # 2. Date of the summary prepared: December 19, 2022 ## 3. Subject Device Information Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) {4}------------------------------------------------ Trade Name: LED Light Therapy Mask Model Name: MK-78, MK-04, MK66-H, EL00003 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulatory Class: II # 4. Predicate Device Information ### Predicate Device 1 Information Sponsor: Harpar Grace International Trade Name: Shani Darden LED light therapy mask Classification Name: Over-the-counter powered light based laser for acne 510(K) Number: K214103 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulation Class: II ## Predicate Device 2 Information Sponsor: ISMART Marketing Svcs Ltd Trade Name: FaceLITE Classification Name: Light based over the counter wrinkle reduction 510(K) Number: K191629 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 878.4810 Regulation Class: II #### 5. Device Description The LED Light Therapy Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles, or mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone. {5}------------------------------------------------ The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED Light Therapy Mask cannot be operated while charging. The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent. Models MK-78, and MK-04 produce red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. For MK-04, the cable for connecting with the controller is nondetachable, but the cable is detachable for MK-78. Model MK-04 contains many rose quartz crystals in inner surface for decoration purpose, the crystals do not contact with skin and there is no therapeutic effect. Model MK66-H and EL00003 produce blue, red, and near infra-red (NIR) light in the visible spectrum (Blue: 415nm, Red: 630+/- 5nm, NIR: 830nm). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller switches the LEDs ON/OFF, controls power to the mask, and switches treatment modes. The cable for connecting with the controller is detachable. Both MK66-H and EL00003 have two pieces of removable eye protection which are for protect eyes from the light. #### 6. Intended Use / Indications for Use For MK-78, MK-04 The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. ## For MK66-H, EL00003 The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles. ## 7. Comparison to predicate device and conclusion {6}------------------------------------------------ Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness. | Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Company | Light Tree Ventures Europe B.V. | Harpar Grace International | ISMART Marketing Svcs Ltd | -- | | Trade Name | LED Light Therapy Mask | Shani Darden LED light therapy mask | FaceLITE | -- | | Classification Name | Light Based Over The Counter Wrinkle Reduction | Over-the-counter powered light based laser for acne | Light Based Over The Counter Wrinkle Reduction | -- | | 510(k) Number | K221775 | K214103 | K191629 | -- | | Product Code | OHS, OLP | OHS, OLP | OHS | Same | | FDA Device Classification | Class II | Class II | Class II | Same | | Use | Over the Counter | Over the counter | Over the counter | Same | | Intended Use / Indications for Use | The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the | The Shani Darden LED light therapy mask is an over-the- counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The Shani Darden LED light therapy mask is an over-the- counter device intended to emit energy in the red and Near Infra-red | The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full- face wrinkles. | Same | | Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | | face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles. | spectrum and is intended for the use in the treatment of full- face wrinkles. | | | | Intended location of use | Face | Face | Face | Same | | Energy Type | Light emitting diodes | Light emitting diodes | Light emitting diodes | Same | | Wavelengths | 1.MK-78, MK-04: Red: 630±5 nm NIR: 830nm 2.MK66-H, EL00003: Blue: 415nm, Red: 630nm +/- 5nm, NIR: 830nm | Blue: 415nm +/- 10nm, Red: 630nm +/- 10nm, NIR: 830nm +/-10nm. | Red: 630nm±10nm NIR: 830nm±10nm | Same | | Total Intensity (mW/cm²) | 1.MK-78: 20-30 mw/cm² 2.MK-04: 30mw/cm² 3.MK66-H, EL00003: (1)Blue/Red 44 mw/cm² (2)Red/NIR 30 mw/cm² | Blue/Red 44 mW/cm² | 30mw/cm² total | Similar Note 1 | | Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | | | Red/NIR 29 mW/cm² | | | | Treatment Time | 10 minutes | 10 minutes | 600 seconds | Same | | Dose | 1.MK-78: 12-18 J/cm² 2.MK-04: 18 J/cm² 3.MK66-H, EL00003: (1)Blue/Red: 26.4 J/cm² (2)Red/NIR: 18 J/cm² | Blue 16.8 J/cm² Red 9.6 J/cm² Red 11 J/cm² NIR 7 J/cm² | 540 J/cm² (cumulative does) | Similar Note 2 | | Treatment protocol | Acne: 4 x weekly, 6 weeks; Wrinkles: 5 x weekly, 6 weeks | Acne: 4 x weekly, 6 weeks; Wrinkles: 5 x weekly, 6 weeks. | 5 x weekly, 6 weeks | Same | | Software controller | Device uses a timer and software to control treatment duration | Device uses a timer and software to control treatment duration | Yes | Same | | Power supply | Rechargeable Lithium battery | 100-240V | Rechargeable Lithium battery | Same | {7}------------------------------------------------ {8}------------------------------------------------ # Comparison in Detail(s): # Note 1: Though there is a minor difference of the "Total Intensity" between the subject and predicate devices, the device passed the testing according to IEC 60601-2-57, such a minor deviation would not affect safety and effectiveness. # Note 2: The dose of the subject device is a single treatment dose calculated based on the total intensity, but the cumulative dose of MK-78, and MK-04 will be equal to the predicate device K191629. And the dose of {9}------------------------------------------------ MK66-H and EL00003 will be almost the same as the predicate device K214103 when the dose of K214103 is calculated according to the total intensity. And the subject device passed the testing according to IEC60601-2-57, so such a minor deviation would not affect safety and effectiveness. ## 8. Test Summary ## 8.1 Summary of Non-Clinical Performance Testing ## 1) Performance Testing Summary The LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003) has been evaluated the safety and performance by lab bench testing as following: | Title of the test | Device Description /Sample Size | Test Method/Ap plicable Standards | Acceptance criteria | Unexpec ted Results/ Significa nt Deviatio ns | Test results | |---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------| | General requirements for basic safety and essential performance | The test sample is the final, finished product. | IEC 60601- 1:2005/AMD 1:2012/AMD 2:2020 | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | NA | Pass | | Electromagnetic disturbances | The test sample is the final, the finished product. | IEC 60601- 1- 2:2014+A1: 2020 | No degradation of performance was found during test or Lower than limits of measurement | NA | Pass | | Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. | The test sample is the final, finished product. | IEC 60601- 1- 11:2015/AM D1:2020 | The device operates normally, and can provide basic safety and essential performance. | NA | Pass | | Particular Requirements for The Basic Safety And Essential | The test sample is the final, finished product. | IEC 60601- 2-57:2011 | The test is carried out under the test method specified in the | NA | Pass | | Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesth etic Use | | | standard, and the test result is within the test acceptance range of the standard. | | | | Photobiological safety of lamps and lamp systems. | The test sample is the final, finished product. | IEC 62471:2006 | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | NA | Pass | | Shelf Life Test | The test sample is the final, finished product. | The Shelf Life Test Report performs the following tests on the product before and after accelerated aging, and after use: Performance test; Power Density Test; Leakage current test. | The device can meet the requirement of the performance test, Power Density test and Leakage current test. | NA | Pass | {10}------------------------------------------------ ## 2) Biocompatibility testing - ISO 10993-1: 2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a . risk management. - EN ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity - . EN ISO 10993-10:2010 ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization {11}------------------------------------------------ ## 3) Usability Testing Usability testing was conducted on the LED Light Therapy Mask (Model: MK-78, MK-04, MK66-H, EL00003), the device complies with IEC 62366-1 and IEC 60601-1-6. ## 4) Software verification and validation testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. ## 8.2 Clinical Performance Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively. ## 9. Final Conclusion: The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K191629 and K214103.