(95 days)
Not Found
No
The device description and performance studies focus on light therapy and electrical/photobiological safety, with no mention of AI or ML.
Yes
The device is indicated for the "treatment of mild to moderate inflammatory acne," which directly implies a therapeutic purpose to address a medical condition.
No
The device is indicated for the treatment of inflammatory acne and uses LED light for this purpose, not for diagnosing conditions.
No
The device description explicitly states it is a "lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs)" and is "made up of a main unit and therapy head," indicating it is a physical hardware device that emits light for therapy. While it mentions software verification and validation, this is for the software controlling the hardware, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device uses LED light therapy applied externally to the skin for the treatment of acne. It does not involve analyzing any biological samples.
- Intended Use: The intended use is for the "treatment of mild to moderate inflammatory acne," which is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and the mechanism of light emission, not on any analytical or testing capabilities.
Therefore, this LED Light Therapy Device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OLP
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed:
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.
Usability Study:
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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: 5~40°C, 41-104° F |
| Relative humidity: 15%-90% | |
| Barometric pressure: 700hPa~1060hPa | |
| Transport and storage environment | Temperature: -25 to 70°C, -13 to 158° F |
| Relative 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±10nm |
| Blue light 417nm±10nm | |
| Effective irradiance | Red light 45 ± 5mW/cm2 |
| Blue 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 |
5
| 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 |
6
| 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±10nm |
| blue light 417nm±10nm | |
| Effective irradiance | Red light 65±5mW/cm2 |
| blue 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 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-7000C2 | 1 | Copy |
6. Intended Use of Device
The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
7
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 Medical | |||
| Equipment Co., Ltd. | Michael Todd, LP | Photo Therapeutics Inc | ------ | |
| Indications for Use | The LED Light Therapy | |||
| Device is indicated for the | ||||
| treatment of mild to moderate | ||||
| inflammatory acne. | The Clear Bi-Light is | |||
| indicated for the treatment of | ||||
| mild to moderate | ||||
| inflammatory acne. | Indicated to treat mild to | |||
| moderate 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) | $417\pm10$ | |||
| $633\pm10$ | 405-420 | |||
| 630-660 | 415±5 | |||
| 633±6 | Substantially equivalent | |||
| Wavelengths are in the blue | ||||
| and red spectrums. | ||||
| Treatment control | " ▶/■ " button to turn the | |||
| irradiator on or off for | ||||
| therapy, hold shoot in contact | ||||
| with skin | On/off button puts device in | |||
| standby mode. | ||||
| Contact sensor in treatment | ||||
| face, touching device to face | ||||
| activates LEDs. | Three position switch: Off – | |||
| Blue - Red | Substantially equivalent | |||
| KN-7000C and Clear Bi-Light | ||||
| have on/off button. Contact | ||||
| sensor in proposed device is | ||||
| the same as in the Clear |
Table 1 Comparison to Predicate Device for KN-7000C
8
| Bi-Light. | ||||
|---|---|---|---|---|
| Treatment indicator | Indicator will light up when | |||
| treatment; the indicator is | ||||
| yellow when charging; the | ||||
| indicator light is green when it | ||||
| is charged fully. | Indicator light-solid green | |||
| while treatment is in process; | ||||
| blinking indicates low battery. | ||||
| Audio signal; long beep when | ||||
| power is turned on, short beep | ||||
| every 30 seconds during | ||||
| treatment; long beep at end of | ||||
| 3 minute cycle. | No | Indicators light substantially | ||
| equivalent to the Clear Bi- | ||||
| Light. Indicators light can | ||||
| indicate related status of the | ||||
| device. | ||||
| Treatment timer | The recommended therapy | |||
| times are 3 minutes per area | ||||
| after which device returns to | ||||
| standby mode. Must press | ||||
| treatment face against skin to | ||||
| reactivate lights. | Up to 3 minutes treatment per | |||
| area after which device | ||||
| returns to standby mode. Must | ||||
| press treatment face against | ||||
| skin to reactivate lights. | No | Same as the Clear Bi-Light. | ||
| Treatment regimen | Hold treatment face in contact | |||
| with skin. Apply blue light for | ||||
| 3minutes per skin area, | ||||
| followed by red light for 3 | ||||
| minutes per skin area. Can be | ||||
| used daily. | Hold treatment face in contact | |||
| with skin. Apply blue light for | ||||
| up to 3minutes per skin area, | ||||
| followed by red light for up to | ||||
| 3 minutes per skin area. Can | ||||
| be used daily. | Alternate treatments of blue | |||
| and red light twice a week | ||||
| for 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) | Substantially | |||
| equivalent-within dose rate | ||||
| ranges of predicate devices. | ||||
| Treatment face | ||||
| area(cm²) | $26\pm10$ % | 20 | 28.7 | Substantially |
| equivalent-within size ranges | ||||
| of predicate devices. | ||||
| Max treatment | ||||
| temperature (°C) | 36.8(blue) | |||
| 36.5(red) | 38(blue) | |||
| 40(red) | 39-43 | Substantially | ||
| equivalent-within temperature | ||||
| ranges of predicate devices | ||||
| Microprocessor | ||||
| controlled | Yes | Yes | Unknown | Same as the Clear Bi-Light. |
| Handheld | Yes | Yes | Yes | Same |
| Patient contacting | ||||
| material | Rigid ABS Clear | |||
| polycarbonate lens cover | Rigid ABS Clear | |||
| polycarbonate lens cover | Rigid ABS Clear | Same | ||
| Power supply | 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 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 | 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 equivalent | |||
| Both are light-weight, hand | ||||
| held devices. | ||||
| Weight | 174g(6.1 oz) | 107.1g(3.8 oz) | Unknown | Substantially equivalent |
| Both are light-weight, hand | ||||
| held devices. | ||||
| Standard | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | Same | |||
| All devices meet the | ||||
| requirements 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 |
9
10
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 Medical | ||||
| Equipment Co., Ltd. | Michael Todd, LP | OmniLux Clear U | ------ | ||
| Indications for Use | The LED Light Therapy | ||||
| Device is indicated for the | |||||
| treatment of mild to moderate | |||||
| inflammatory acne. | The Clear Bi-Light is | ||||
| indicated for the treatment | |||||
| of mild to moderate | |||||
| inflammatory acne. | Indicated to treat mild to | ||||
| moderate 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 and | |||||
| red light treatment heads). | |||||
| Wavelength(s) | |||||
| (mm) | $417\pm10$ | ||||
| $633\pm10$ | 405-420 | ||||
| 630-660 | $415\pm5$ | ||||
| $633\pm6$ | Substantially equivalent | ||||
| Wavelengths are in the blue | |||||
| and red spectrums | |||||
| Treatment control | “ ▶/■ ” button to turn the | ||||
| irradiator on or off for | |||||
| therapy, The treatment head | |||||
| should rest against the skin | |||||
| area to be treated. | On/off button puts device in | ||||
| standby mode. | |||||
| Contact sensor in treatment | |||||
| face, touching device to face | |||||
| activates LEDs. | Three position switch: Off – | ||||
| Blue - Red | Substantially equivalent | ||||
| KN-7000C and Clear Bi-Light | |||||
| have on/off button. Contact | |||||
| sensor in proposed device is | |||||
| the same as in the Clear Bi- | |||||
| Light. | |||||
| Treatment indicator | Indicator will light up when | ||||
| treatment; the indicator is | |||||
| yellow when charging; the | |||||
| indicator light is green when | |||||
| it is charged fully. | Indicator light-solid green | ||||
| while treatment is in process; | |||||
| blinking indicates low battery. | |||||
| Audio signal; long beep when | |||||
| power is turned on, short beep | |||||
| every 30 seconds during | |||||
| treatment; long beep at end of | |||||
| 3 minute cycle. | No | Indicators light substantially | |||
| equivalent to the Clear Bi- | |||||
| Light. Indicators light can | |||||
| indicate related status of the | |||||
| device. | |||||
| Treatment timer | The recommended therapy | ||||
| times are 2 minutes per area | |||||
| after which device returns to | |||||
| standby mode. Must press | |||||
| treatment face against skin to | |||||
| reactivate lights. | Up to 3 minutes treatment per | ||||
| area after which device | |||||
| returns to standby mode. | |||||
| Must press treatment face | |||||
| against skin to reactivate | |||||
| lights. | No | Substantially equivalent to the | |||
| Clear Bi-Light. Both devices | |||||
| limit treatment to within 3 | |||||
| minutes. | |||||
| Treatment regimen | Hold treatment face in contact | ||||
| with skin. Apply blue light for | |||||
| 2minutes per skin area, | |||||
| followed by red light for 2 | |||||
| minutes per skin area. Can be | |||||
| used daily. | Hold treatment face in contact | ||||
| with skin. Apply blue light for | |||||
| up to 3minutes per skin area, | |||||
| followed by red light for up to | |||||
| 3 minutes per skin area. Can | |||||
| be used daily. | Alternate treatments of blue | ||||
| and red light twice a week for | |||||
| 20 minutes per treatment. | Substantially equivalent to the | ||||
| Clear Bi-Light. Both devices | |||||
| limit treatment to within 3 | |||||
| minutes. | |||||
| 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. 2A | |||||
| Main unit input: 5V d.c. 2A/Internal battery: 3.6Vd.c. 2200mAh | |||||
| Internal 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 | Same | |
| All devices meet the | |||||
| requirements 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 |
11
12
13
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.
14
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:
15
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
16
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.
--- End of this section ---