(95 days)
The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
The LED Light Therapy Device is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm) and/or in the blue light region of the spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. This device is made up of a main unit and therapy head. The light gathering cover is also referred to as the snoot. The snoot helps to establish the correct treatment distance.
The document describes a 510(k) premarket notification for a medical device called "LED Light Therapy Device" (Models KN-7000C and KN-7000C2), indicated for the treatment of mild to moderate inflammatory acne. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with quantifiable metrics like sensitivity or specificity.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or effect size for AI improvement) is not present in the provided text. The submission relies on demonstrating similarity to already cleared predicate devices.
However, the document does contain information about non-clinical tests performed to ensure safety and usability. These non-clinical tests can be considered as acceptance criteria for regulatory compliance and device safety/functionality rather than clinical efficacy.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with "acceptance criteria" in terms of clinical performance metrics, nor does it report specific clinical performance against such criteria. Instead, it demonstrates compliance with recognized safety and electrical standards, and usability.
Non-Clinical Acceptance Criteria and Reported Performance (Based on provided text):
| Acceptance Criteria Category | Specific Acceptance Standard/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009/C1:2010 (Evaluation and Testing for devices in contact with intact skin, including in vitro cytotoxicity, skin sensitization, and skin irritation) | All tests passed: ISO10993-5:2009 (cytotoxicity), ISO10993-10:2010 (irritation and skin sensitization) |
| ISO10993-5:2009 (Biological evaluation of medical devices-Part 5: tests for in vitro cytotoxicity) | Passed | |
| ISO10993-10:2010 (Biological evaluation of medical devices-Part10: tests for irritation and skin sensitization) | Passed | |
| Electrical Safety & EMC | AAMI/ANSI ES60601-1: 2005/(R)2012 and A1:2012., C1:2009/(R)2012 and A2:2010/(R)2012 (Medical electrical equipment-Part 1: General requirements for basic safety and essential performance) | Complies with applicable requirements |
| IEC 60601-1-2:2014 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests) | Complies with applicable requirements | |
| IEC 60601-1-11:2015 (Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) | Complies with applicable requirements | |
| IEC 60601-2-57:2011 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests) | Complies with applicable requirements | |
| Photobiological Safety | IEC 62471:2006 (Photobiological safety of lamps and lamp systems, 1st edition, incorporating principles of ANSI IESNA RP 27.1, RP 27.2, and RP-27.3) | Complies with IEC 62471:2006 |
| Software V&V | Software documentation consistent with moderate level of concern; System validation testing to confirm all software requirement specifications are met and all software hazards mitigated. | All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Usability | Participants (lay users) able to correctly answer questions about the product, self-select appropriateness, and understand the user manual. | All participants correctly answered questions and self-selected; provided feedback for manual improvement. |
2. Sample Size for Test Set and Data Provenance
- Non-Clinical Tests (Biocompatibility, Electrical Safety, Photobiological Safety, Software V&V): The document does not specify a "sample size" in terms of number of devices for these tests. These are typically performed on a representative sample or prototype.
- Usability Study:
- Sample Size: "The required number of participants was obtained through networking, social media and advertising in the local newspaper." A specific number is not given, but implies a sufficient number for a usability assessment.
- Data Provenance: Conducted in Hudson Falls, NY, USA. The study appears to be prospective for evaluating the device's usability with human participants.
3. Number of Experts for Ground Truth & Qualifications
Not applicable. This was a non-clinical evaluation for regulatory compliance and substantial equivalence, not a clinical study requiring expert-established ground truth for performance metrics.
For the usability study, the "ground truth" was essentially the participants' ability to understand and use the device. The evaluators were the participants themselves, and the study was conducted by Dave Oberhelman, Plant/Compliance Manager at UVBioTek.
4. Adjudication Method
Not applicable. No clinical ground truth requiring adjudication methods was established.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document describes a 510(k) submission based on substantial equivalence and non-clinical testing. It does not include a comparative effectiveness study, especially one involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is an LED light therapy device, not an AI or software algorithm that would have "standalone performance" in the typical sense of diagnostic or prognostic AI. The "software verification and validation" (Section 9) refers to the embedded software in the device, ensuring its functional correctness and safety, not a standalone clinical performance evaluation.
7. Type of Ground Truth Used
- For Non-Clinical Tests: The "ground truth" was adherence to established international and national standards (ISO, IEC, AAMI/ANSI).
- For Usability Study: The "ground truth" was the participants' demonstrated ability to understand and operate the device correctly, and their feedback on the user manual.
8. Sample Size for Training Set
Not applicable. The document does not describe a machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable. No training set for an AI algorithm was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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 10, 2018
Uvbiotek, LLC % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, 511660 Cn
Re: K180900
Trade/Device Name: LED Light Therapy Device 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: OLP Dated: April 6, 2018 Received: April 13, 2018
Dear Jinghua Zhou:
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. 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name LED Light Therapy Device
Indications for Use (Describe) The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
__ Prescription Use (Part 21 CFR 801 Subpart D)
🇿 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Section 5 - 510(k) Summary
Date of Summary Preparation: April 3, 2018
1. Submitter's Identifications
Submitter's Name: UVBIOTEK, LLC Address: 3 Depot Street, Hudson Falls, NY 12839, United States Contact Person: Dave Oberhelman Contact Title: Plant Manager Contact E-mail Address: info@uvbiotek.com Telephone: 518-747-3310 Fax: 518-747-2294
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: kernel 2016@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Over-The-Counter Powered Light Based Laser For Acne Product Name: Over-The-Counter Powered Light Based Laser For Acne Trade Name: LED Light Therapy Device Model: KN-7000C, KN-7000C2 Classification Panel: General & Plastic Surgery Product Code: OLP Device Classification: Class II
4. The Predicate Devices
Clear Bi-Light K153081 K081307 OmniLux Clear U
5. Device Description
The LED Light Therapy Device is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm) and/or in the blue light region of the spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne.
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This device is made up of a main unit and therapy head. The light gathering cover is also referred to as the snoot. The snoot helps to establish the correct treatment distance.
Description for KN-7000C:
The device uses 48 LED cold light sources, and uses an external removable single cell lithium ion battery for power, with a continuous usage time of 120 minutes. It can be charged using a power adapter.
The LED information:
| Items | Red head | Blue head |
|---|---|---|
| LED numbers | 48 | 48 |
| Total spectrum peak wavelength | 633nm±10nm | 417nm±10nm |
| Total effective irradiance | 45mW/cm2 ± 5mW/cm2 | 25mW/cm2 ± 5mW/cm2 |
| Total luminous power | 1.3W | 0.78W |
| Total energy fluxes | 9J/cm2 | 5.4J/cm2 |
The specification table is as below:
SPECIFICATIONS
| Model | KN-7000C |
|---|---|
| Safety classification | Class II, has internal power source. |
| Operating mode | Continuous operation |
| IP rating | IP22 |
| Adapter model number | LXCP12-005200DEG, Input: 100-240V a.c. 50/60Hz, 0.5A max. Output: 5V d.c. 2A |
| Main unit | input: 5V d.c. 2A/Internal battery: 3.6Vd.c. 2200mAh |
| Internal battery specification | CR18650-22F 3.6V d.c. 2200mAh |
| Working environment | Temperature: 5 |
| Transport and storage environment | Temperature: -25 to 70°C, -13 to 158° FRelative humidity: ≤90 %Barometric pressure: 500~1060hPa |
| Structural configuration | Handheld |
| Display style | No |
| Effective configuration area | 26cm2±10% |
| Irradiance distance | Hold treatment face in contact with skin |
| Spectrum peak wavelength | Red light 633nm±10nmBlue light 417nm±10nm |
| Effective irradiance | Red light 45 ± 5mW/cm2Blue light 25 ± 5mW/cm2 |
| Timing and functions | The device has a timer, with a timing error of less than±2% of the pre-set value |
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| The device has the function of manually stopping | |
|---|---|
| irradiation output. | |
| Operation noise | Not exceed 60dB(A) |
The list of accessories
| No. | Name | Specifications | Quantity | Unit |
|---|---|---|---|---|
| 1 | Adapter | LXCP12-005200DEG | 1 | Piece |
| 2 | Protective eyewear | YH-8 | 1 | Pieces |
| 3 | Manual | User Manual | 1 | Copy |
| 4 | Certificate | KN-7000C | 1 | Copy |
Description for KN-7000C2:
The device uses 8 LED cold therapy heads and has high stability, strong uniformity, and a long lifespan. It uses an external removable single cell lithium ion battery for power, with a continuous usage time of 4.5 hours. It can be charged using a power adapter.
The LED information:
| Items | Red head | Blue head |
|---|---|---|
| LED numbers | 8 | 8 |
| Total spectrum peak wavelength | 633nm±10nm | 417nm±10nm |
| Total effective irradiance | 65mW/cm2 ± 5mW/cm2 | 35mW/cm2 ± 5mW/cm2 |
| Total luminous power | 0.28W | 0.16W |
| Total energy fluxes | 8.4J/cm2 | 4.8J/cm2 |
The specification table is as below:
SPECIFICATIONS
| Model | KN-7000C2 |
|---|---|
| Safety classification | Class II, has internal power source. |
| Operating mode | Continuous operation |
| IP rating | IP22 |
| Adapter model number | LXCP12-005200DEG, Input: 100-240V a.c. 50/60Hz, |
| 0.5A max. Output: 5V d.c. 2A | |
| Main unit | input: 5V d.c. 2A/Internal battery: 3.6Vd.c. 2200mAh |
| Internal battery specification | CR18650-22F 3.6V d.c. 2200mAh |
| Working environment | Temperature: 5〜40°C , 41-104°F |
| Relative humidity: 15%-90% | |
| Barometric pressure: 700hPa~1060hPa | |
| Transport and storage environment | Temperature: -25 to 70℃, -13 to 158°F |
| Relative humidity: ≤90 % | |
| Barometric pressure: 500~1060hPa |
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| Structural configuration | Handheld |
|---|---|
| Display style | OLED display |
| Effective configuration area | 4cm2±10% |
| Irradiance distance | Hold treatment face in contact with skin |
| Spectrum peak wavelength | Red light 633nm±10nmblue light 417nm±10nm |
| Effective irradiance | Red light 65±5mW/cm2blue light 35±5mW/cm2 |
| Timing and functions | The device has a timer, with a timing error of less than±2% of the pre-set value.The device has the function of manually stoppingirradiation output. |
| Operation noise | Not exceed 60dB(A) |
The list of accessories
| No. | Name | Specifications | Quantity | Unit |
|---|---|---|---|---|
| 1 | Adapter | LXCP12-005200DEG | 1 | Piece |
| 2 | Protective eyewear | YH-8 | 1 | Pieces |
| 3 | Manual | User Manual | 1 | Copy |
| 4 | Certificate | KN-7000C2 | 1 | Copy |
6. Intended Use of Device
The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
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7. Summary of Substantial Equivalence
| Proposed Device | Predicate device | Predicate device | Comparison | |
|---|---|---|---|---|
| 510k Number | ------ | K153081 | K081307 | ------ |
| Product Code | OLP | OLP | OLP | Same |
| Proprietary Name | LED Light Therapy Device | Clear Bi-Light | OmniLux Clear U | ------ |
| Model | KN-7000C | / | / | ------ |
| Manufacturer | Xuzhou Kernel MedicalEquipment Co., Ltd. | Michael Todd, LP | Photo Therapeutics Inc | ------ |
| Indications for Use | The LED Light TherapyDevice is indicated for thetreatment of mild to moderateinflammatory acne. | The Clear Bi-Light isindicated for the treatment ofmild to moderateinflammatory acne. | Indicated to treat mild tomoderate acne on the face. | Same |
| OTC or Rx | OTC | OTC | OTC | Same |
| Energy source | LED | LED | LED | Same |
| Treatment heads | Separate blue and red,treatment heads | Separate blue and red,treatment heads | Blue and Red in same head,chosen using selector switch | Same |
| Wavelength(s)(nm) | $417\pm10$$633\pm10$ | 405-420630-660 | 415±5633±6 | Substantially equivalentWavelengths are in the blueand red spectrums. |
| Treatment control | " ▶/■ " button to turn theirradiator on or off fortherapy, hold shoot in contactwith skin | On/off button puts device instandby mode.Contact sensor in treatmentface, touching device to faceactivates LEDs. | Three position switch: Off –Blue - Red | Substantially equivalentKN-7000C and Clear Bi-Lighthave on/off button. Contactsensor in proposed device isthe same as in the Clear |
Table 1 Comparison to Predicate Device for KN-7000C
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| Bi-Light. | ||||
|---|---|---|---|---|
| Treatment indicator | Indicator will light up whentreatment; the indicator isyellow when charging; theindicator light is green when itis charged fully. | Indicator light-solid greenwhile treatment is in process;blinking indicates low battery.Audio signal; long beep whenpower is turned on, short beepevery 30 seconds duringtreatment; long beep at end of3 minute cycle. | No | Indicators light substantiallyequivalent to the Clear Bi-Light. Indicators light canindicate related status of thedevice. |
| Treatment timer | The recommended therapytimes are 3 minutes per areaafter which device returns tostandby mode. Must presstreatment face against skin toreactivate lights. | Up to 3 minutes treatment perarea after which devicereturns to standby mode. Mustpress treatment face againstskin to reactivate lights. | No | Same as the Clear Bi-Light. |
| Treatment regimen | Hold treatment face in contactwith skin. Apply blue light for3minutes per skin area,followed by red light for 3minutes per skin area. Can beused daily. | Hold treatment face in contactwith skin. Apply blue light forup to 3minutes per skin area,followed by red light for up to3 minutes per skin area. Canbe used daily. | Alternate treatments of blueand red light twice a weekfor 20 minutes per treatment. | Same as the Clear Bi-Light. |
| Dose rate(mW/cm²) | $25\pm5$ (blue)$45\pm5$ (red) | 31.1(blue)54.6(red) | 40(blue)70(red) | Substantiallyequivalent-within dose rateranges of predicate devices. |
| Treatment facearea(cm²) | $26\pm10$ % | 20 | 28.7 | Substantiallyequivalent-within size rangesof predicate devices. |
| Max treatmenttemperature (°C) | 36.8(blue)36.5(red) | 38(blue)40(red) | 39-43 | Substantiallyequivalent-within temperatureranges of predicate devices |
| Microprocessorcontrolled | Yes | Yes | Unknown | Same as the Clear Bi-Light. |
| Handheld | Yes | Yes | Yes | Same |
| Patient contactingmaterial | Rigid ABS Clearpolycarbonate lens cover | Rigid ABS Clearpolycarbonate lens cover | Rigid ABS Clear | Same |
| Power supply | Adapter model number:LXCP12-005200DEG, Input:100-240V a.c. 50/60Hz, 0.5Amax. Output: 5V d.c. 2AMain unit input: 5V d.c.2A/Internal battery: 3.6Vd.c.2200mAhInternal battery specifications:CR18650-22F 3.6V d.c.2200mAh | Lithium-ion rechargeablebattery AC charger: 100-240Vat 50-60 Hz, 500mA | A separate, universal, powersupply converts mains ACpower to the DC powerrequired | Substantially equivalent to theClear Bi-Light. All deviceshave power adapter. |
| Dimensions | 257mm×165mm×70mm(10.1in×6.5in×2.8in) | 6.4cm×3.5cm×14.6cm(2.5in×1.4in×5.7in) | 6cm×4cm×12cm(2.4in×1.6in×4.7in) | Substantially equivalentBoth are light-weight, handheld devices. |
| Weight | 174g(6.1 oz) | 107.1g(3.8 oz) | Unknown | Substantially equivalentBoth are light-weight, handheld devices. |
| Standard | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | SameAll devices meet therequirements of effectiveness,safety and biocompatibility. |
| IEC 62471 | IEC 62471 | IEC 62471 | ||
| ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | ||
| ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-10 | ISO 10993-10 |
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Table 2 Comparison to Predicate Device for KN-7000C2
| Proposed Device | Predicate device | Predicate device | Comparison | ||
|---|---|---|---|---|---|
| 510k Number | ------ | K153081 | K081307 | ------ | |
| Product Code | OLP | OLP | OLP | Same | |
| Proprietary Name | LED Light Therapy Device | Clear Bi-Light | OmniLux Clear U | ------ | |
| Model | KN-7000C2 | / | / | ------ | |
| Manufacturer | Xuzhou Kernel MedicalEquipment Co., Ltd. | Michael Todd, LP | OmniLux Clear U | ------ | |
| Indications for Use | The LED Light TherapyDevice is indicated for thetreatment of mild to moderateinflammatory acne. | The Clear Bi-Light isindicated for the treatmentof mild to moderateinflammatory acne. | Indicated to treat mild tomoderate acne on the face. | Same | |
| OTC or Rx | OTC | OTC | OTC | Same | |
| Energy source | LED | LED | LED | Same | |
| Treatment heads | Separate blue and red,treatment heads | Separate blue and red,treatment heads | Blue and Red in same head,chosen using selector switch | Same as the Clear Bi-Light(both offer separate blue andred light treatment heads). | |
| Wavelength(s)(mm) | $417\pm10$$633\pm10$ | 405-420630-660 | $415\pm5$$633\pm6$ | Substantially equivalentWavelengths are in the blue | |
| and red spectrums | |||||
| Treatment control | “ ▶/■ ” button to turn theirradiator on or off fortherapy, The treatment headshould rest against the skinarea to be treated. | On/off button puts device instandby mode.Contact sensor in treatmentface, touching device to faceactivates LEDs. | Three position switch: Off –Blue - Red | Substantially equivalentKN-7000C and Clear Bi-Lighthave on/off button. Contactsensor in proposed device isthe same as in the Clear Bi-Light. | |
| Treatment indicator | Indicator will light up whentreatment; the indicator isyellow when charging; theindicator light is green whenit is charged fully. | Indicator light-solid greenwhile treatment is in process;blinking indicates low battery.Audio signal; long beep whenpower is turned on, short beepevery 30 seconds duringtreatment; long beep at end of3 minute cycle. | No | Indicators light substantiallyequivalent to the Clear Bi-Light. Indicators light canindicate related status of thedevice. | |
| Treatment timer | The recommended therapytimes are 2 minutes per areaafter which device returns tostandby mode. Must presstreatment face against skin toreactivate lights. | Up to 3 minutes treatment perarea after which devicereturns to standby mode.Must press treatment faceagainst skin to reactivatelights. | No | Substantially equivalent to theClear Bi-Light. Both deviceslimit treatment to within 3minutes. | |
| Treatment regimen | Hold treatment face in contactwith skin. Apply blue light for2minutes per skin area,followed by red light for 2minutes per skin area. Can beused daily. | Hold treatment face in contactwith skin. Apply blue light forup to 3minutes per skin area,followed by red light for up to3 minutes per skin area. Canbe used daily. | Alternate treatments of blueand red light twice a week for20 minutes per treatment. | Substantially equivalent to theClear Bi-Light. Both deviceslimit treatment to within 3minutes. | |
| Dose rate | 35±5(blue) | 31.1(blue) | 40(blue) | Substantially | |
| (mW/cm²) | 65±5(red) | 54.6(red) | 70(red) | equivalent-within dose rate ranges of predicate devices. | |
| Treatment face area(cm²) | 4±10% | 20 | 28.7 | Substantially equivalent-within size ranges of predicate devices | |
| Max treatment temperature(°C) | 37.5(blue)37.0(red) | 38(blue)40(red) | 39-43 | Substantially equivalent-within temperature ranges of predicate devices | |
| Microprocessor controlled | Yes | Yes | Unknown | Same | |
| Handheld | Yes | Yes | Yes | Same | |
| Patient contacting material | Rigid ABS Clear polycarbonate lens cover | Rigid ABS Clear polycarbonate lens cover | Rigid ABS | Same | |
| Power supply | Adapter model number:LXCP12-005200DEG, Input:100-240V a.c. 50/60Hz, 0.5A max. Output: 5V d.c. 2AMain unit input: 5V d.c. 2A/Internal battery: 3.6Vd.c. 2200mAhInternal battery specifications: CR18650-22F 3.6V d.c. 2200mAh | Lithium-ion rechargeable battery AC charger: 100-240V at 50-60 Hz, 500mA | A separate, universal, power supply converts mains AC power to the DC power required | Substantially equivalent to the Clear Bi-Light. All devices have power adapter. | |
| Dimensions | 231mm×159mm×68mm(9.1in×6.3in×2.7in) | 6.4cm×3.5cm×14.6cm(2.5in×1.4in×5.7in) | 6cm×4cm×12cm(2.4in×1.6in×4.7in) | Substantially equivalent All devices are light-weight, hand held devices. | |
| Weight | 122g(4.3 oz) | 107.1g(3.8 oz) | Unknown | Substantially equivalent to the Clear Bi-Light Both are | |
| light-weight, hand held devices. | |||||
| Standard | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | SameAll devices meet therequirements of effectiveness,safety and biocompatibility. | |
| IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | |||
| IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | |||
| IEC 60601-2-57 | IEC 60601-2-57 | IEC 60601-2-57 | |||
| IEC 62471 | IEC 62471 | IEC 62471 | |||
| ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | |||
| ISO 10993-5 | ISO 10993-5 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-10 | ISO 10993-10 |
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8. Substantial Equivalence discussion:
The indication for use of the KN-7000C LED Light Therapy Device and KN-7000C2 LED Light Therapy Device are the for the predicate devices. Most technical specifications of the KN-7000C LED Light Therapy Device and KN-7000C2 LED Light Therapy Device are either the same or substantially equivalent as compared to the predicate devices that raise new or different questions of safety of effectiveness.
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9. Non-Clinical Tests Performed:
The following non-clinical testing was provided in this 510(k):
Biocompatibility Testing - The skin contacting materials of the device were subjected to biocompatibility testing per ISO 10993-1:2009/C1:2010, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing," for devices in contact with intact skin, including in vitro cytotoxicity, skin sensitization, and skin irritation. All tests passed. The tests comply with the applicable requirements of the following standards:
ISO10993-5:2009, Biological evaluation of medical devices-Part 5: tests for in vitro cytotoxicity.
ISO10993-10:2010, Biological evaluation of medical devices-Part10: tests for irritation and skin sensitization.
Electrical Safety and Electromagnetic Compatibility Testing - The KN-7000C LED Light Therapy Device and KN-7000C2 LED Light Therapy Device have been tested and comply with the applicable requirements of the following standards for medical devices used in the home environment:
● AAMI/ANSI ES60601-1: 2005/(R)2012 and A1:2012., C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
· IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
· IEC 60601-1-11:2015 Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
· IEC 60601-2-57:2011 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
Photobiological Safety Testing - The KN-7000C LED Light Therapy Device and KN-7000C2 LED Light Therapy Device have been tested and comply with IEC 62471:2006, Photobiological safety of lamps and lamp systems, 1st edition. This IEC standard incorporates the principles of the following ANSI IESNA recommended practices:
· RP 27.1:2005 Recommended practice for photobiological safety for lamps and lamp systems -General requirements
· RP 27.2:2000 Recommended practice for photobiological safety for lamps and lamp systems -Measurement techniques
· RP-27.3:2007 Recommended practice for photobiological safety for lamps and lamp systems -Risk group classification and labeling
Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
10. Usability Study:
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The KN-7000C LED Light Therapy Device and KN-7000C2 LED Light Therapy Device were performed usability study separately by similar methods.
Usability study summary of KN-7000C LED Light Therapy Device:
This usability Study was started on 1/7/2018 at 3 Depot Street, Hudson Falls, NY, USA.
It was conducted by Dave Oberhelman, Plant/Compliance Manager, UVBioTek
The study was completed on 2/1/2018.
The required number of participants was obtained through networking, social media and advertising in the local newspaper.
All of the participants were able to correctly answer the questions as listed in Appendix 1 and Appendix 2 All the participants were able to self select whether or not the product was correct for them. Some of the participants did not have acne but they would purchase the product for their children who did have acne.
Most of the participants offered suggestions to change the wording to make different parts of the manual easier to read and understand.
The original user manual for this study is in section 5 of this binder. The participant improved version is in section 7 of this binder.
The packaging materials used in the 1st part of this study will be e-mailed to Jonny Chen, of Kernel Medical, because they will not fit in this binder.
The following are samples of some of the suggestions the participants made to make the user manual easier to understand. Reference to page numbers applies to the new updated version of the manual.
State that the treatment heads have color dots on the back to identify what color LED is placed inside the treatment head Page 6 & 7.
List "How to take a treatment" in the table of contents.
Define what a snoot is. Page 9.
Remove 1% mild detergent and replace with diluted, non-corrosive, mild detergent Page 23.
State "Press and Hold" the power button. Page 14.
State at the very beginning that this device has two different color treatment heads. Page 1.
Change "operation mode" to "treatment time selection". Page 10
Change "work mode" button to "treatment time selector". Page 9
State "start treatment with blue LED treatment head". Page 14
State "Install the red treatment head and complete the treatment". Page 15
Define what it means to be insensitive to heat. Add (can not feel heat). Page 1
State that the time setting and treatment start must be completed with in 30 seconds or the unit will
shut off to conserve the battery. Page 14
Move the LED Life statement to page 20.
Usability study summary of KN-7000C2 LED Light Therapy Device:
This usability Study was started on 1/20/2018 at 3 Depot Street. Hudson Falls, NY, USA.
It was conducted by Dave Oberhelman, Plant/Compliance Manager, UVBioTek
T he study was completed on 2/4/2018.
The required number of participants was obtained through networking, social media and advertising in the local newspaper.
All of the participants were able to correctly answer the questions as listed in Appendix 1 and
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Appendix 2 All the participants were able to self select whether or not the product was correct for them. Some of the participants did not have acne but they would purchase the product for their children who did have acne.
This study was started after the 7000C was started The User Manuals, Warnings, Cautions, Contraindications and package artwork are very similar. Most of the improvements obtained by the 7000C study were incorporated in to the artwork and user manual for the 7000C2, before the 7000C2 study started. The participants did not have any suggestions for improvements because all the material was easy to understand.
Some of the participants noticed that question # 10 in Appendix # 2 did not have a correct answer. Answer 'B" showed "(1)" but is should have shown " (1)". These participants were very good evaluators.
The original user manual for this study is in section 5 of this binder. The participant improved version is in section 7 of this binder.
The packaging materials used in the 1st part of this study will be e-mailed to Jonny Chen, of Kernel Medical, because they will not fit in this binder.
11. Conclusion:
Based on comparing to predicate device, the proposed device of KN-7000C and KN-7000C2 are determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.
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§ 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.