Nooance Led And Laser Helmet

K231321 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · OAP · Jul 31, 2023 · Physical Medicine

Device Facts

• Record ID: K231321
• Device Name: Nooance Led And Laser Helmet
• Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
• Product Code: OAP · Physical Medicine
• Decision Date: Jul 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NOOANCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Device Story

Helmet-based phototherapy device; utilizes 650nm low-level laser diodes (LDs) and light-emitting diodes (LEDs) to irradiate hair follicles. Two models: M-120 (51 LDs, 69 LEDs) and M-282 PRO (82 LDs, 200 LEDs). Operated by patient at home; features continuous and pulse modes; 25-minute fixed treatment time. Includes auto-pause/resume functionality when removed from head. Provides red light therapy to stimulate hair growth. Powered by lithium-ion battery. User interface includes ON/OFF and start/pause buttons; audible beeps signal treatment completion. Intended to benefit patients by promoting hair regrowth in androgenetic alopecia.

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), non-laser light source safety (IEC 60601-2-57), photobiological safety (IEC 62471), and laser safety (IEC 60825-1). Biocompatibility established via predicate comparison.

Technological Characteristics

Helmet form factor; 650±5nm wavelength red light (LDs and LEDs). M-120: 51 LDs/69 LEDs; M-282 PRO: 82 LDs/200 LEDs. Lithium-ion battery powered. Class 1C laser classification per IEC 60825-1. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471.

Indications for Use

Indicated for males (Hamilton-Norwood IIa-V) and females (Ludwig-Savin I-II) with androgenetic alopecia and Fitzpatrick Skin Phototypes I-IV to promote hair growth.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• iRestore Professional 282 (K183417)
• Irradiation Cosmetic Device (HairPro Plus) (K192552)
• CurrentBody Skin™ LED Hair Regrowth (MZ-07) (K230336)

Submission Summary (Full Text)

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July 31, 2023

Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra CEO Building#3 and Building#5, 40th of Fuxin Street Huaide Community, Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China

Re: K231321

Trade/Device Name: Nooance Led And Laser Helmet Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: May 6, 2023 Received: May 8, 2023

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.

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K231321

Device Name NOOĀNCE LED AND LASER HELMET (Model: M-120, M-282 PRO)

Indications for Use (Describe)

The NOOANCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Prescription Use (Part 801 CFR Subpart D) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Over-The-Counter Use (801 CFR 801 Subpart C) |

|_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary of K231321

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### 1. Submitter Information

Sponsor Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact name: Alain Dijkstra (CEO) Tel: [phone] Fax: [phone] E-mail: [e-mail]

# Distributor

Company Name: NOOANCE INNOVATIONS Address: 22 Rue Beaujon, 75008 Paris, France

# Application Correspondent:

Contact Person: Mr. Alain Dijkstra Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Tel: [phone] Fax: [phone] Email: [e-mail]

#### 2. Summary Prepared Date

6 May, 2023

#### Subject Device Information 3.

Trade Name: NOOÃNCE LED AND LASER HELMET Model: M-120, M-282 PRO Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II

#### 4. Predicate Device Information Predicate Device 1

Sponsor: Raymond R. Blanche Common Name: Laser, Comb, Hair Classification Name: Infrared Lamp Trade Name: iRestore Professional 282

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510(K) Number: K183417 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II

# Predicate Device 2

Sponsor: Chongqing Peninsula Medical Technology Co., Ltd. Trade Name: Irradiation Cosmetic Device Model: HairPro Plus 510(k) Number: K192552 Common Name: Laser, Comb, Hair Classification Name: Infrared lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: Class II

### Predicate Device 3

Sponsor: Light Tree Ventures Europe B.V. Trade Name: CurrentBody Skin™ LED Hair Regrowth Model: MZ-07 510(k) Number: K230336 Common Name: Laser, Comb, Hair Classification Name: Infrared lamp Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: Class II

#### 5. Device Description

The NOOANCE LED AND LASER HELMET is an over-the-counter device designed to promote hair growth in person with androgenetic alopecia in women and men. The device is a combination of 650±5nm low-level laser diodes and 650±5nm light emitting diodes. Red light of specific spectrum combined with low-lever laser directly irradiated into hair follicles has been shown to help promote hair growth. It has two models, M-120 and M-282 PRO. The difference between them is the number of laser diodes (LDs) and light-emitting diodes (LEDs). The model M-120 is a combination of 51 class 1C low-level LDs and 69 LEDs. And the model M-282 PRO has 82 class 1C low-level LDs and 200 LEDs.

The device has two working modes. Mode 1 is continuous which has no frequency setting. Mode 2 is pulse with a frequency. User long presses the ON/OFF button to turn on the device and tap the ON/OFF button to select the preferred mode. Then press the start/pause button to start the treatment, treatment time is fixed for 25 minutes. The device is designed to automatically pause therapy if it is removed from the head and resume therapy when positioned on the head within 5 minutes and the start/pause button is pressed. Once the treatment complete, the device will turn off automatically with two "beep" sounds.

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#### 6. Indications for Use

The NOOÃNCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

#### 7. Comparison to Predicate Devices

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3 | Verdict |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | Shenzhen Kaiyan<br>Medical Equipment<br>Co., Ltd | Raymond<br>R.<br>Blanche | Chongqing<br>Peninsula<br>Medical<br>Technology<br>Co., Ltd. | Light<br>Ventures<br>Europe<br>B.V. | -- |
| Trade Name | NOOĀNCE LED AND<br>LASER HELMET | iRestore<br>Professional<br>282 | Irradiation<br>Cosmetic<br>Device | CurrentBody<br>Skin™<br>LED<br>Hair<br>Regrowth | -- |
| Model | M-120, M-282 PRO | / | HairPro Plus | MZ-07 | / |
| 510(k)<br>Number | K231321 | K183417 | K192552 | K230336 | -- |
| Common<br>name | Laser, Comb, Hair | Laser,<br>Comb,<br>Hair | Laser,<br>Comb,<br>Hair | Laser,<br>Comb,<br>Hair | Same |
| Classification<br>Name | Infrared Lamp | Infrared Lamp | Infrared lamp | Infrared lamp | Same |
| Review panel | General & Plastic<br>Surgery | General<br>&<br>Plastic Surgery | General<br>&<br>Plastic Surgery | General<br>&<br>Plastic Surgery | Same |
| Product<br>Code | OAP | OAP | OAP | OAP | Same |
| Regulation<br>number | 21 CFR 890.5500 | 21<br>CFR<br>890.5500 | 21 CFR<br>890.5500 | 21<br>CFR<br>890.5500 | Same |
| Regulation<br>Class | Class II | Class II | Class II | Class II | Same |
| Intended Use<br>/ Indications<br>for Use | The NOOĀNCE LED<br>AND LASER<br>HELMET is indicated<br>to promote hair<br>growth in males with<br>androgenetic<br>alopecia who have<br>Hamilton-Norwood<br>Classifications of IIa-<br>V and Fitzpatrick<br>Classification of Skin<br>Phototypes I to IV | The iRestore<br>Professional<br>282<br>is<br>indicated<br>to<br>promote<br>hair<br>growth<br>in<br>females<br>with<br>androgenetic<br>alopecia<br>who<br>have<br>Ludwig-Savin<br>Classifications | The Irradiation<br>Cosmetic<br>Device is<br>indicated<br>to<br>promote<br>hair<br>growth<br>in<br>females<br>with<br>androgenetic<br>alopecia<br>who<br>have Ludwig-<br>Savin<br>Classifications | The<br>CurrentBody<br>Skin™<br>Led<br>Hair Regrowth<br>(MZ-07) is<br>indicated<br>to<br>treat<br>Androgenetic<br>Alopecia<br>and<br>to<br>Promote<br>Hair<br>Growth<br>in | Same |
| Elements of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3 | Verdict |
| | and females with<br>androgenetic<br>alopecia who have<br>Ludwig-Savin<br>Classifications of I-II<br>and Fitzpatrick<br>Classification of Skin<br>Phototypes I to IV. | of I-II, males<br>who have<br>Norwood-<br>Hamilton<br>Classifications<br>of IIa-V and for<br>both,<br>Fitzpatrick<br>Classification<br>of Skin<br>Phototypes I to<br>IV. | of I - II and<br>males with<br>androgenetic<br>alopecia who<br>have Norwood-<br>Hamilton<br>Classifications<br>of IIa - V and<br>for both,<br>Fitzpatrick<br>Classification<br>of Skin<br>Phototypes I to<br>IV | males who<br>have<br>Norwood-<br>Hamilton<br>Classifications<br>of IIa - V<br>patterns of hair<br>loss and to<br>treat<br>Androgenetic<br>Alopecia and<br>Promote Hair<br>Growth in<br>females who<br>have Ludwig-<br>Savin<br>Scale I-1 to I-<br>4, II -1, II-2 or<br>frontal patterns<br>of hair loss;<br>both with<br>Fitzpatrick<br>Skin Types I -<br>IV. | |
| Type for use | OTC | OTC | OTC | OTC | Same |
| Intended<br>User | Females & Males | Females &<br>Males | Females &<br>Males | Females &<br>Males | Same |
| Type of light | Low-level laser<br>diodes and light<br>emitting diodes | Low-level laser<br>diodes and<br>light emitting<br>diodes | Visible red<br>laser | Visible red<br>light-emitting<br>diodes | Same as<br>K183417 |
| Wavelength | Laser: 650±5 nm<br>Red light LED: 650±5<br>nm | 650 ±10 nm | 650±5 nm | 660 nm | Same |
| Number of<br>diodes | M-120:<br>LDs: 51<br>LEDs: 69<br>M-282 PRO:<br>LDs: 82<br>LEDs: 200 | LDs: 82<br>LEDs: 200 | 272 | 120 | Similar<br>Note 1 |
| Irradiance | M-120: approximately<br>1.3 mw/cm²<br>M-282 PRO:<br>approximately 2.8<br>mw/cm² | Not available | 2.7454<br>mw/cm² | 1.67 mw/cm² | Similar<br>Note 2 |
| Fluence | M-120: approximately | Not available | 4.9417 J/cm2 | 1 J/cm² | Similar |
| Elements of<br>Comparison | Subject Device | Predicate<br>Device 1 | Predicate<br>Device 2 | Predicate<br>Device 3 | Verdict |
| | 1.9 J/cm²<br>M-282 PRO:<br>approximately 4.2<br>J/cm² | | | | Note 2 |
| Distribution | Uniform distribution | Uniform<br>distribution | Uniform<br>distribution | Uniform<br>distribution | Same |
| Laser<br>classification<br>according to<br>IEC 60825-1 | Class 1C | Class 3R | Class 3R | Not available | Different<br>Note 3 |
| Power output | < 5 mW from each<br>laser or LED | Not available | 5mW ±10% | Not available | Same |
| Treatment<br>protocol | 25 minutes every<br>other day for 16<br>weeks | 16 weeks, for<br>25 minutes<br>treatment<br>times, three<br>times a week<br>on alternate<br>days | Each<br>Treatment: 30<br>min<br>Total<br>Treatment: 3<br>times per week | Every day 10<br>mins | Same as<br>K183417 |
| Power<br>Supply | Lithium-ion battery | Not available | Not available | lithium battery | Same as<br>K230336 |

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# Comparison in Detail(s):

# Note 1:

Although the "Number of diodes" of the subject device is different from the predicate device, since the specifications between them is different, but the energy is similar. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

# Note 2:

The "Irradiance" and the "Fluence" of Model M-282 PRO is similar predicate device K192552. The "Irradiance" and the "Fluence" of Model M-120 is similar predicate device K230336. Although not exactly the same, the parameters are very close. So, we think the little difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

# Note 3:

Although the "Laser classification according to IEC 60825-1" of the subject device is different from the predicate device, the subject device conducted the safety test according to the IEC 60825-1 standards, and all the test results are in compliance with safety standards' requirements. So, the difference between the subject device and the predicate device will not raise any safety or effectiveness issues.

#### 8. Test Summary

# 8.1 Summary of Non-Clinical Performance Testing

# 1) Performance Testing Summary

The NOOANCE LED AND LASER HELMET (Model: M-120, M-282 PRO) has been evaluated the safety and performance by lab bench testing as following:

| Title of the test | Device | Test | Acceptance | Unexpected | Test |
|-------------------|--------|------|------------|------------|------|
|-------------------|--------|------|------------|------------|------|

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| | Descriptio<br>n/Sample<br>Size | Method/Ap<br>plicable<br>Standards | criteria | cted<br>Results/<br>Signific<br>ant<br>Deviatio<br>ns | result<br>s |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------|
| General<br>requirements<br>for basic safety<br>and essential<br>performance | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>1: Edition<br>3.2 2020-08 | The test is<br>carried out<br>under the test<br>method<br>specified in the<br>standard, and<br>the test result<br>is within the<br>test<br>acceptance<br>range of the<br>standard. | NA | Pass |
| Electromagneti<br>c disturbances | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>1-2: Edition<br>4.1 2020-09 | No degradation<br>of performance<br>was found<br>during test or<br>Lower than<br>limits of<br>measurement. | NA | Pass |
| Requirements<br>for medical<br>electrical<br>equipment and<br>medical<br>electrical<br>systems used<br>in the home<br>healthcare<br>environment | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>1-11:<br>Edition 2.1<br>2020-07 | The device<br>operates<br>normally, and<br>can provide<br>basic safety<br>and essential<br>performance. | NA | Pass |
| Particular<br>Requirements<br>for The Basic<br>Safety And<br>Essential<br>Performance Of<br>Non-Laser Light<br>Source<br>Equipment<br>Intended For<br>Therapeutic,<br>Diagnostic,<br>Monitoring And | The test<br>sample is<br>the final,<br>finished<br>product. | IEC 60601-<br>2-57:<br>Edition 1.0<br>2011-01 | The test is<br>carried out<br>under the test<br>method<br>specified in the<br>standard, and<br>the test result<br>is within the<br>test<br>acceptance<br>range of the<br>standard. | NA | Pass |

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| Page | 7 | of 8 |
|------|---|------|
|------|---|------|

| Cosmetic/Aesthetic Use | | | | | |
|-------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----|------|
| Photobiological safety of lamps and lamp systems. | The test sample is the final, finished product. | IEC 62471:<br>First edition 2006-07 | 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 |
| Safety of laser products - Part 1: Equipment classification, and requirements | The test sample is the final, finished product. | IEC 60825-1:<br>Edition 2.0 2007-03 | 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 |

# 2) Biocompatibility

The component materials for Outer Shell of the helmet and the controller are identical to the corresponding component for Shell of the CurrentBody Skin™ Led Hair Regrowth (Model: MZ-07) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents), that manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd and has been cleared in K230336 on April 05, 2023.

# 3) Usability Testing

Usability testing was conducted on the NOOÃNCE LED AND LASER HELMET (Model: M-120, M-282 PRO), 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.

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# 5) Cybersecurity

The subject device has no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

# 7.2 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. Conclusion

When compared to the predicate devices, the subject device does not raise new types of questions with regard to safety and effectiveness. After an analysis of intended use, performance, safety, and technological characteristics, the sponsor believes that it has demonstrated that the subject device can be operated safely and effectively for the proposed indications for use, and that it be considered as substantially equivalent to the legally marketed predicated devices K183417, K192552 and K230336.