(84 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and study proving device performance:
Crucial Observation: The provided document is an FDA 510(k) clearance letter and its accompanying summary. It explicitly states in section 8.2: "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."
Therefore, a study demonstrating the device meets performance criteria for hair growth promotion (which would typically involve clinical data) has not been provided or deemed necessary for this 510(k) clearance. The acceptance criteria and "study" described below refer primarily to the non-clinical performance and safety testing.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
1. Table of Acceptance Criteria and Reported Device Performance
| Test Title | Acceptance Criteria | Reported Performance |
|---|---|---|
| General requirements for basic safety and essential performance (IEC 60601-1) | Test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances (IEC 60601-1-2) | No degradation of performance was found during the test or lower than limits of measurement. | Pass |
| Requirements for medical electrical equipment & systems in home healthcare (IEC 60601-1-11) | Device operates normally, and can provide basic safety and essential performance. | Pass |
| Particular Requirements for Basic Safety & Essential Performance of Non-Laser Light Source Equipment (IEC 60601-2-57) | Test result is within the test acceptance range of the standard. | Pass |
| Photobiological safety of lamps and lamp systems (IEC 62471) | Test result is within the test acceptance range of the standard. | Pass |
| Safety of laser products - Part 1: Equipment classification & requirements (IEC 60825-1) | Test result is within the test acceptance range of the standard. | Pass |
| Biocompatibility | Component materials for outer shell and controller are identical to predicate device materials cleared in K230336 in formulation, processing, sterilization, and geometry, with no other chemicals added. | Compliant (Similar to K230336) |
| Usability Testing (IEC 62366-1, IEC 60601-1-6) | Device complies with the standards. | Complies |
| Software Verification & Validation | Documentation provided as recommended by FDA guidance. Considered "moderate" level concern, as malfunction would likely lead to Minor Injury. | Conducted, Documentation Provided |
| Cybersecurity | No external interfaces, adhering to FDA guidance. | Compliant (No external interfaces) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For all non-clinical performance tests (electrical safety, EMC, photobiological safety, laser safety), the "test sample is the final, finished product." This generally implies that a representative number of units (typically 1-3, but not explicitly stated as a statistical sample for a clinical trial) were subjected to these engineering and safety tests.
- Data Provenance: The tests are described as lab bench testing performed on the final product. The document does not specify the country of origin where these lab tests were conducted. The application is from Shenzhen, China, so it's likely the tests were conducted there or by a certified lab associated with the manufacturer. The data is retrospective in the sense that results are reported after the testing has been completed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable in the traditional sense of clinical ground truth. Since no clinical study was conducted for efficacy claims relating to hair growth, there were no "experts" establishing a clinical ground truth for a test set of patients.
- The "ground truth" for these tests comes from adherence to international standards (e.g., IEC 60601, IEC 62471, IEC 60825-1). The experts involved would be the test engineers and certification bodies performing and validating the adherence to these specific technical standards. Their qualifications would be in electrical engineering, safety testing, and compliance with the specified standards.
4. Adjudication Method for the Test Set
- None. As this is non-clinical safety and performance testing, there is no need for a clinical adjudication method (like 2+1 or 3+1 consensus). The "adjudication" is simply whether the measured performance passes or fails the pre-defined criteria of the relevant international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for evaluating the performance of AI/CAD systems in medical imaging, often comparing human reader performance with and without AI assistance. This device is a direct-to-consumer LED/Laser helmet for hair growth, not an AI diagnostic tool. Therefore, an MRMC study was neither conducted nor applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No. This device is a physical therapeutic device, not an algorithm. There is no "standalone" algorithm performance to evaluate. The device's performance is its physical output (light wavelength, irradiance, fluence) and safety features, which were tested against engineering standards.
7. The Type of Ground Truth Used
- Engineering and Safety Standards: The "ground truth" for the non-clinical testing is compliance with established international medical device safety and performance standards (e.g., IEC 60601 series, IEC 62471, IEC 60825-1). For biocompatibility, it was established by similarity to a previously cleared predicate device. For software, ground truth was adherence to FDA guidance.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains 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.
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 (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
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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)
| Prescription Use (Part 801 CFR Subpart D) |
|---|
| 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: 0755-82129361 Fax: 0755-25024651 E-mail: regulation@kaiyanmedical.com
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: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
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 ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | Verdict |
|---|---|---|---|---|---|
| Company | Shenzhen KaiyanMedical EquipmentCo., Ltd | RaymondR.Blanche | ChongqingPeninsulaMedicalTechnologyCo., Ltd. | LightVenturesEuropeB.V. | -- |
| Trade Name | NOOĀNCE LED ANDLASER HELMET | iRestoreProfessional282 | IrradiationCosmeticDevice | CurrentBodySkin™LEDHairRegrowth | -- |
| Model | M-120, M-282 PRO | / | HairPro Plus | MZ-07 | / |
| 510(k)Number | K231321 | K183417 | K192552 | K230336 | -- |
| Commonname | Laser, Comb, Hair | Laser,Comb,Hair | Laser,Comb,Hair | Laser,Comb,Hair | Same |
| ClassificationName | Infrared Lamp | Infrared Lamp | Infrared lamp | Infrared lamp | Same |
| Review panel | General & PlasticSurgery | General&Plastic Surgery | General&Plastic Surgery | General&Plastic Surgery | Same |
| ProductCode | OAP | OAP | OAP | OAP | Same |
| Regulationnumber | 21 CFR 890.5500 | 21CFR890.5500 | 21 CFR890.5500 | 21CFR890.5500 | Same |
| RegulationClass | Class II | Class II | Class II | Class II | Same |
| Intended Use/ Indicationsfor Use | The NOOĀNCE LEDAND LASERHELMET is indicatedto promote hairgrowth in males withandrogeneticalopecia who haveHamilton-NorwoodClassifications of IIa-V and FitzpatrickClassification of SkinPhototypes I to IV | The iRestoreProfessional282isindicatedtopromotehairgrowthinfemaleswithandrogeneticalopeciawhohaveLudwig-SavinClassifications | The IrradiationCosmeticDevice isindicatedtopromotehairgrowthinfemaleswithandrogeneticalopeciawhohave Ludwig-SavinClassifications | TheCurrentBodySkin™LedHair Regrowth(MZ-07) isindicatedtotreatAndrogeneticAlopeciaandtoPromoteHairGrowthin | Same |
| Elements ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | Verdict |
| and females withandrogeneticalopecia who haveLudwig-SavinClassifications of I-IIand FitzpatrickClassification of SkinPhototypes I to IV. | of I-II, maleswho haveNorwood-HamiltonClassificationsof IIa-V and forboth,FitzpatrickClassificationof SkinPhototypes I toIV. | of I - II andmales withandrogeneticalopecia whohave Norwood-HamiltonClassificationsof IIa - V andfor both,FitzpatrickClassificationof SkinPhototypes I toIV | males whohaveNorwood-HamiltonClassificationsof IIa - Vpatterns of hairloss and totreatAndrogeneticAlopecia andPromote HairGrowth infemales whohave Ludwig-SavinScale I-1 to I-4, II -1, II-2 orfrontal patternsof hair loss;both withFitzpatrickSkin Types I -IV. | ||
| Type for use | OTC | OTC | OTC | OTC | Same |
| IntendedUser | Females & Males | Females &Males | Females &Males | Females &Males | Same |
| Type of light | Low-level laserdiodes and lightemitting diodes | Low-level laserdiodes andlight emittingdiodes | Visible redlaser | Visible redlight-emittingdiodes | Same asK183417 |
| Wavelength | Laser: 650±5 nmRed light LED: 650±5nm | 650 ±10 nm | 650±5 nm | 660 nm | Same |
| Number ofdiodes | M-120:LDs: 51LEDs: 69M-282 PRO:LDs: 82LEDs: 200 | LDs: 82LEDs: 200 | 272 | 120 | SimilarNote 1 |
| Irradiance | M-120: approximately1.3 mw/cm²M-282 PRO:approximately 2.8mw/cm² | Not available | 2.7454mw/cm² | 1.67 mw/cm² | SimilarNote 2 |
| Fluence | M-120: approximately | Not available | 4.9417 J/cm2 | 1 J/cm² | Similar |
| Elements ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | Verdict |
| 1.9 J/cm²M-282 PRO:approximately 4.2J/cm² | Note 2 | ||||
| Distribution | Uniform distribution | Uniformdistribution | Uniformdistribution | Uniformdistribution | Same |
| Laserclassificationaccording toIEC 60825-1 | Class 1C | Class 3R | Class 3R | Not available | DifferentNote 3 |
| Power output | < 5 mW from eachlaser or LED | Not available | 5mW ±10% | Not available | Same |
| Treatmentprotocol | 25 minutes everyother day for 16weeks | 16 weeks, for25 minutestreatmenttimes, threetimes a weekon alternatedays | EachTreatment: 30minTotalTreatment: 3times per week | Every day 10mins | Same asK183417 |
| PowerSupply | Lithium-ion battery | Not available | Not available | lithium battery | Same asK230336 |
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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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| Description/SampleSize | Method/ApplicableStandards | criteria | ctedResults/SignificantDeviations | results | |
|---|---|---|---|---|---|
| Generalrequirementsfor basic safetyand essentialperformance | The testsample isthe final,finishedproduct. | IEC 60601-1: Edition3.2 2020-08 | The test iscarried outunder the testmethodspecified in thestandard, andthe test resultis within thetestacceptancerange of thestandard. | NA | Pass |
| Electromagnetic disturbances | The testsample isthe final,finishedproduct. | IEC 60601-1-2: Edition4.1 2020-09 | No degradationof performancewas foundduring test orLower thanlimits ofmeasurement. | NA | Pass |
| Requirementsfor medicalelectricalequipment andmedicalelectricalsystems usedin the homehealthcareenvironment | The testsample isthe final,finishedproduct. | IEC 60601-1-11:Edition 2.12020-07 | The deviceoperatesnormally, andcan providebasic safetyand essentialperformance. | NA | Pass |
| ParticularRequirementsfor The BasicSafety AndEssentialPerformance OfNon-Laser LightSourceEquipmentIntended ForTherapeutic,Diagnostic,Monitoring And | The testsample isthe final,finishedproduct. | IEC 60601-2-57:Edition 1.02011-01 | The test iscarried outunder the testmethodspecified in thestandard, andthe test resultis within thetestacceptancerange of thestandard. | 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: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: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.
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.