(87 days)
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,
The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.
The mask is worn on the face and is held in place by head straps , The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.
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 HIGHERDOSE Red And Infrared Light 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.
The provided document is a 510(k) premarket notification for a medical device (HIGHERDOSE Red and Infrared Light Mask). It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than presenting a detailed clinical study for novel performance claims.
Therefore, the information required to fully answer your request regarding acceptance criteria and performance studies for an AI/software-based device, particularly those concerning human-in-the-loop performance, expert ground truth, and training data provenance, is not present in this document.
However, I can extract the information provided about the non-clinical performance testing of this light therapy mask, which is a hardware device with some embedded software for control (e.g., timer).
Here's a breakdown of what can be inferred and what is explicitly stated:
Device: HIGHERDOSE Red and Infrared Light Mask (MK66-L)
Indications for Use: The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
Non-Clinical Performance Testing (Hardware and Embedded Software)
The document lists several non-clinical performance tests conducted, relevant to the safety and fundamental operation of the device, rather than its clinical efficacy in treating wrinkles which is established by substantial equivalence to predicates.
1. A table of acceptance criteria and the reported device performance
| Title of the test | Acceptance criteria | Test results |
|---|---|---|
| General requirements for basic safety and essential performance (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. | Pass |
| Electromagnetic disturbances (IEC 60601-1-2:2014+A1:2020) | No degradation of performance was found during test or Lower than limits of measurement | Pass |
| Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015/AMD1:2020) | The device operates normally and can provide basic safety and essential performance. | Pass |
| Particular Requirements for The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use (IEC 60601-2-57:2011) | 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. | Pass |
| Photobiological safety of lamps and lamp systems (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. | Pass |
| Shelf Life Test | The device can meet the requirement of the performance test, Power Density test and Leakage current test. | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size: "The test sample is the final, finished product." For each test, it implies at least one production unit was tested. The specific number of units is not stated, but typically for these types of tests, a small representative sample or even a single unit is sufficient to demonstrate compliance with standards.
- Data Provenance: Not specified, but generally, these tests are conducted by accredited labs. The manufacturer is based in Shenzhen, Guangdong, China. These are typically lab bench tests, not involving human subjects or real-world data collection in the sense of a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided. These are engineering/safety/performance tests against established international standards, not diagnostic device studies requiring medical expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. These are objective engineering tests with pass/fail criteria based on standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC or comparative effectiveness study was conducted or reported. This device is a direct-to-consumer light therapy mask, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an AI algorithm. The device has embedded software for basic control (like a timer), and "Software verification and validation testing" was conducted for this embedded software, considered a "moderate" level concern. However, this is not a standalone AI algorithm being evaluated for diagnostic or interpretive performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is adherence to the specified international safety and performance standards (e.g., IEC 60601-1, IEC 62471), determined through objective measurements and validated test methodologies.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a "training set." The embedded software is deterministic and not trained on data.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned for this product.
Summary regarding AI/Software-based device criteria:
The provided document is not for a device that fits the typical "AI/software-based device" criteria you've outlined (e.g., requiring MRMC studies, expert ground truth for image interpretation, or large training datasets). This 510(k) is for a hardware device (a light therapy mask) with embedded software for basic functionality (like a timer). The review focuses on demonstrating safety, fundamental performance, and substantial equivalence to existing predicate devices based on non-clinical engineering and safety standards. No clinical efficacy study data is presented, as it was deemed "not needed for this 510(k)" due to the substantial equivalence pathway.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra Regulatory Affairs Engineer Building #3 and Building #5, 40th of Fuxin Street Huaide Community Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China
Re: K241933
Trade/Device Name: HIGHERDOSE Red and Infrared Light Mask (MK66-L) 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 Dated: June 12, 2024 Received: July 2, 2024
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 (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/ofdocs/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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K241933 - Alain Dijkstra
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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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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/deviceadvice-comprehensive-regulatory-assistance/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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE - ○ Date: 2024.09.27
23:22:48 -04'00'
Tanisha Hithe 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
HIGHERDOSE RED AND INFRARED LIGHT MASK (MK66-L)
Indications for Use (Describe)
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in 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)
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K241933
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Establishment Registration Number: 3011644607 Address: Building #3, and Building#5 40th of Fuxin street, Huaide Community, Fuyong Town, Baoan District, Shenzhen, Guangdong, 518103, China Contact Person (including title): Alain Dijkstra Tel: +86 755 82129361 Fax: +86 755 25024651 E-mail: alaindijkstra@kaiyanmedical.com
Distributor
Company Name: HIGHERDOSE LLC Address: 42 Broadway, 12th Floor, #212, NewYork, NY 10004 Establishment Registration Number: 3019734322 Contact Person: Sumish Khadka E-mail: sumish@higherdose.com
Manufacturer:
Manufacturer 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 Person (including title): Alain Dijkstra Tel: +86 755 82129361 Fax: +86 755 25024651 E-mail: alaindijkstra@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra Company: 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
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Fax: +86 755 25024651 E-mail: regulation@kaiyanmedical.com
2. Date of the summary prepared: September 26, 2024
3.Subject Device Information
Classification Name: Light Based Over-The Counter Wrinkle Reduction (OHS) Trade Name: HIGHERDOSE Red And Infrared Light Mask Model Name: MK66-L Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 878.4810 Regulatory Class: II
4. Predicate Device Information
Predicate Device 1 Information
Sponsor: Light Tree Ventures Europe B.V Trade Name: LED Light Therapy Mask Classification Name: Light based over the counter wrinkle reduction 510(K) Number: K221775 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Requlation Class: II
Predicate Device 2 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 3 Information
Sponsor: ISMART Marketing Svcs Ltd Trade Name: FaceLITE
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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
Predicate Device 4 Information
Sponsor: SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Trade Name: Aduro Light Beauty Mask Classification Name: Light based over the counter wrinkle reduction 510(K) Number: K202390 Review Panel: General & Plastic Surgery Product Code: OHS,OLP Regulation Number: 878.4810 Requlation Class: II
5. Device Description
The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles,
The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking.
The mask is worn on the face and is held in place by head straps , The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone.
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 HIGHERDOSE Red And Infrared Light 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.
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6. Intended Use / Indications for Use
For MK-66L
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
7. Comparison to predicate device and conclusion
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 | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | PredicateDevice 4 | Remark |
|---|---|---|---|---|---|---|
| Company | HigherDOSE LLC | Light TreeVenturesEurope B.V. | Harpar GraceInternational | ISMARTMarketingSvcs Ltd | Shenzhen KaiyanMedicalEquipment Co.,Ltd | -- |
| Trade Name | HigherDose LightFace Mask | LED LightTherapyMask | Shani DardenLED lighttherapy mask | FaceLITE | Aduro LightBeauty Mask | -- |
| ClassificationName | Light Based OverThe CounterWrinkleReduction | Light BasedOver TheCounterWrinkleReduction | Over-the-counterpowered lightbased laserfor acne | Light BasedOver TheCounterWrinkleReduction | Light BasedOver-The-CounterWrinkle Reduction | -- |
| 510(k)Number | TBD | K221775 | K214103 | K191629 | K202390 | -- |
| ProductCode | OHS | OHS, OLP | OHS, OLP | OHS | OHS,OLP | Same |
| FDA DeviceClassification | Class II | Class II | Class II | Class II | Class II | Same |
| Use | Over the Counter | Over theCounter | Over thecounter | Over thecounter | Over the counter | Same |
| IntendedUse /Indicationsfor Use | TheHIGHERDOSERed And InfraredLight Mask(Model: MK66-L)is an over the | The LEDLight TherapyMask(Models: MK-78, MK-04) isan over the | The ShaniDarden LEDlight therapymask is anover-the-counter | The faceLITELED mask isan over thecounter devicethat isintended for | The Aduro LightBeauty Mask(Model: MK-660,MK-66USBO, MK-020) emits energyin the red andblue region of thespectrum, | Same |
| Elements ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | PredicateDevice 4 | Remark |
| counter devicethat is intended forthe use in thetreatment of full-face wrinkles. | counterdevice that isintended forthe use in thetreatment offull-facewrinkles. | deviceintended toemit energy inthe red andblue region ofthe lightspectrum,specificallyindicated totreat mild tomoderateacne vulgarisof the face.The ShaniDarden LEDlight therapymask is anover-the-counterdeviceintended toemit energy inthe red andNear Infra-redspectrum andis intended forthe use in thetreatment offull-facewrinkles. | the use in thetreatment offull-facewrinkles. | indicated to treatfull face wrinklesand/or mild tomoderate acne. | ||
| The LEDLight TherapyMask(Models:MK66-H,EL00003) isan over thecounterdeviceintended toemit energyin the red andblue region ofthe lightspectrum,specificallyindicated totreat mild tomoderateacne vulgarisof the face.The LEDLight TherapyMask(Models:MK66-H, | ||||||
| Elements ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | PredicateDevice 4 | Remark |
| EL00003) isan over thecounterdeviceintended toemit energyin the red andNear Infra-redspectrum andis intendedfor the use inthe treatmentof full-facewrinkles. | ||||||
| Intendedlocation ofuse | Face | Face | Face | Face | Face | same |
| Energy Type | Light emittingdiodes | Light emittingdiodes | Light emittingdiodes | Light emittingdiodes | Light emittingdiodes | Same |
| Wavelengths | Red:630nm±10nmNIR:830nm±10nm | 1.MK-78, MK-04:Red: 630±5nmNIR: 830nm2.MK66-H,EL00003:Blue: 415nm,Red: 630nm+/- 5nm,NIR: 830nm | Blue: 415nm+/- 10nm,Red: 630nm+/- 10nm,NIR: 830nm+/-10nm. | Red:630nm±10nmNIR:830nm±10nm | Red:640nm±10nmBlue:465nm±10nm | Same |
| Elements ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | PredicateDevice 4 | Remark |
| TotalIntensity(mW/cm²) | Red 20mw/cm²,Infrared Red :30mw/cm² | 1.MK-78: 20-30 mw/cm²2.MK-04:30mw/cm²3.MK66-H,EL00003:(1)Blue/Red44 mw/cm²(2)Red/NIR30 mw/cm² | Blue/Red 44mW/cm²Red/NIR 29mW/cm² | 30mw/cm²total | 30mw/cm² | same |
| TreatmentTime | 10 minutes | 10 minutes | 10 minutes | 600 seconds | ||
| Dose | Red 12, InfraredRed: 18 J/cm² | 1.MK-78: 12-18 J/cm²2.MK-04: 18J/cm²3.MK66-H,EL00003:(1)Blue/Red:26.4 J/cm²(2)Red/NIR:18 J/cm² | Blue 16.8J/cm²Red 9.6 J/cm²Red 11 J/cm²NIR 7 J/cm² | 540 J/cm²(cumulativedoes) | Same | |
| Treatmentprotocol | 3-5 times /week | Acne: 4 xweekly, 6weeks;Wrinkles: 5 xweekly, 6weeks | Acne: 4 xweekly, 6weeks;Wrinkles: 5 xweekly, 6weeks. | 5 x weekly, 6weeks | ||
| Softwarecontroller | Device uses atimer and software | Device usesa timer and | Device uses atimer and | Yes | Device uses atimer and software | Same |
| Elements ofComparison | Subject Device | PredicateDevice 1 | PredicateDevice 2 | PredicateDevice 3 | PredicateDevice 4 | Remark |
| to controltreatment duration | software tocontroltreatmentduration | software tocontroltreatmentduration | to controltreatment duration | |||
| Powersupply | RechargeableLithium battery | RechargeableLithiumbattery | 100-240V | RechargeableLithium battery | RechargeableLithium battery | Same |
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Final Conclusion:
The subject device is the same or similar to the legally marketed predicate device K221775, K214103, K191629 and K202390.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1) Performance Testing Summary
The HIGHERDOSE Red And Infrared Light Mask (Model: MK-66L) has been evaluated the safety and performance by lab bench testing as following:
| Title of the test | DeviceDescription/SampleSize | TestMethod/ApplicableStandards | Acceptancecriteria | UnexpectedResults/SignificantDeviations | Testresults |
|---|---|---|---|---|---|
| Generalrequirements forbasic safety andessentialperformance | The testsample isthe final,finishedproduct. | IEC 60601-1:2005/AMD1:2012/AMD2:2020 | The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard. | NA | Pass |
| Electromagneticdisturbances | Thetestsample isthefinal,finishedproduct. | IEC 60601-1-2:2014+A1:2020 | No degradationof performancewasfoundduring test orLowerthanlimitsofmeasurement | NA | Pass |
| Requirementsfor medicalelectrical | Thetestsample isthefinal | IEC 60601-1-11:2015/AM | Thedeviceoperatesnormally and | NA | Pass |
| equipment andmedicalelectricalsystems used inthe homehealthcareenvironment. | finishedproduct. | D1:2020 | can providebasic safetyand essentialperformance. | ||
| ParticularRequirementsfor The BasicSafety AndEssentialPerformance OfNon-Laser LightSourceEquipmentIntended ForTherapeutic,Diagnostic,Monitoring AndCosmetic/Aesthetic Use | The testsample isthe final,finishedproduct. | IEC 60601-2-57:2011 | The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard. | NA | Pass |
| Photobiologicalsafety of lampsand lampsystems. | The testsample isthe final,finishedproduct. | IEC62471:2006 | The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard. | NA | Pass |
| Shelf Life Test | The testsample isthe final,finishedproduct. | The Shelf LifeTest Reportperforms thefollowing testson the productbefore andafteracceleratedaging, andafter use:Performancetest;Power DensityTest;Leakagecurrent test. | The device canmeet therequirement of theperformance test,Power Densitytest and Leakagecurrent test. | NA | Pass |
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2) Biocompatibility testing
The component materials of the subject device are identical to the corresponding component materials of the previously cleared devices ( K202390) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents).
Here is no change in biocompatibility since the previously cleared devices. Therefore, based on this information, the subject device can comply with the biocompatibility requirements of ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), and ISO 10993-10 (Irritation).
3) Usability Testing
Usability testing was conducted on the HIGHERDOSE Red And Infrared Light Mask, 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 K221775, K214103, K191629 and K202390.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.