(142 days)
Not Found
No
The summary describes a light therapy device with different wavelengths for various dermatological and pain conditions. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on electrical, photobiological, and software safety, not on algorithmic performance.
Yes
The device is intended to treat dermatological conditions, moderate inflammatory acne vulgaris, periorbital wrinkles and rhytides, and provide temporary relief for minor muscle and joint pain, arthritis, and muscle spasm, which are all therapeutic claims.
No
The device description and intended use clearly state that this is a therapy device (LED light therapy) designed to treat dermatological conditions, pain, and stiffness by emitting energy. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it is composed of a main frame, an irradiator (containing LEDs), and a lifting stand, which are physical hardware components. The intended use also describes the emission of energy from these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a light therapy device for treating dermatological conditions and providing temporary relief for muscle and joint pain. These are applications that involve direct interaction with the patient's body, not the examination of specimens taken from the body.
- Device Description: The description details a physical device with LED panels that emit light. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, and photobiological safety, which are relevant for a light-emitting medical device, not an IVD.
In summary, the device's function, intended use, and testing all point towards it being a therapeutic medical device that applies light to the body, not an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (599±10nm) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain. arthritis and musele spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LED Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10mm), yellow light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm).
The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light).
Composition : The instrument is mainly composed of a main frame, an irradiator, and a lifting stand.
Equipment functions:
- Light source is extensible according to the areas to be treated to realize large-area irradiation.
- Light source is arranged in matrix, making it more suitable for facial treatment.
- Fixing and electrical connection of the light source is realized through a quick connector, making the replacement more convenient and fast.
- Design of free-lifting cantilever allows the light source to stay at any position and angle.
- 10.4" touch screen simplifies the operation and eliminates the need for professional training.
- 5 commonly used treatment schemes can be stored to avoid repeated setting.
- Warm voice guide makes it easy for you to operate.
- Effective irradiance of the light source can be adjusted according to the treatment need.
- Double switch protection of power switch and power-on password, no need to worry about being misused.
- Non-invasive operation, no damage to skin cells.
- No special care is required after treatment, and makeup can be applied normally.
Instrument type:
Protection against electric shock: Class I.
Operating mode: continuous operation.
An enclosed apparatus that is not protected against liquid ingress.
Equipment that cannot be used in the presence of flammable anesthetic gas mixed with air or with oxygen or nitrous oxide.
Main performance indicators
Power supply: AC 100-240V±10%, 50/60 Hz±2% Input power: 600V A Fuse specification, model & rating:T8.0AL/250V Φ5*20 Structure: wheeled Display mode: LCD display Effective irradiation area: 900cm2 ± 10% Irradiation distance: 6cm±1cm Spectral peak wavelength: Red light: 633 nm± 10 nm; Blue light: 417 nm±10 nm; Yellow light: 590 nm±10 nm; Infrared: 835nm±15nm.
Effective irradiance: The error between the effective irradiance and the nominal value indicated in the nameplate shall be no more than ±25%, and the effective irradiance shall be not more than 200mW/cm2.
Red light: 2096mW/cm2;120mW/cm2;
Blue light: 10
Yellow light: 535mW/cm2;166mW/cm²,
Infrared ≤ 70mW/cm2.
Red/IR: 20
Blue/IR: 10~190mW/cm²
Working noise:
Under normal working conditions, the noise generated by the instrument shall not exceed 60dB (A).
Stand adjustment:
Under normal working condition, the stand can be adjusted up, down, left and right, and the irradiator can be fixed at any angle.
Timing and functions
The device has a timer with an error not greater than ±2% of the set value, Continuous working time ≤ 99min;
The function of manually stopping radiation output can be realized through the software pause and stop buttons.
Replaceable irradiator.
Treatment can be preset.
The instrument has a calibration function.
The instrument has a time mode.
The instrument has a dose mode.
The instrument has two functions of continuous output and pulse output.
Accessories: Main frame, Irradiator (Irradiator BRY or Irradiator BRI for option), Protective goggles (for doctors, patients), Power cord, Fuse, Tools (hex wrench (8mm, 4mm, 5mm and 2mm) and screwdriver, 1 for each), M310 screw, M615 hexagon socket head cap screw, Upper hole plug, lower hole plug, seal plug, Instructions for Use, Certificate of Conformity.
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
Not Found
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:
Electrical Safety and Electromagnetic Compatibility Testing - KN-7000L LED Light therapy equipment has been tested and meets the following standard requirements of medical equipment:
● IEC60601-1: 2005+2005+CORR.1:2006+CORR.2:2007+A1:2012 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 60601-2-57:2011 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-7000L 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.
Conclusion:
Based on comparing to predicate device, the proposed device of KN-7000L are determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 1, 2023
Xuzhou Kernel Medical Equipment Co., Ltd. % Shanfeng Jiang Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 304. Building A. No. 62 Nanvun 2nd Road. Science Town Huangpu District, Guangzhou City, Guangdong 510663 China
Re: K222751
Trade/Device Name: LED Light Therapy Device, KN-7000L 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: GEX Dated: December 5, 2022 Received: December 5, 2022
Dear Shanfeng Jiang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name
LED Light Therapy Device
Indications for Use (Describe)
LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain. arthritis and musele spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
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) |
|---|---|
| -------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- |
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3
Section 5 - 510(k) Summary
K222751
Date of Summary Preparation: September 12, 2022 Update to current: January 31, 2023
1. Submitter's Identifications
Submitter's Name: Xuzhou Kernel Medical Equipment Co., Ltd. Address: Kernel Mansion, Economic Development District, Xuzhou City, Jiangsu Province, China Contact Person: Cuiling Xi Contact Title: Management representative Contact E-mail Address: mananger@kernelmed.com Telephone: +86-516-87732208
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: Jiang13620586569@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Device Classification Name: Laser surgical instrument for use in general and plastic surgery and
in dermatology Trade Name: LED Light Therapy Device Model: KN-7000L Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II Regulation Number:21 CFR878.4810
4. The Predicate Devices
Phototherapy Systems K190938 K200104 Oxylight
5. Device Description
5.1 Device introduction:
The LED Light Therapy Device uses specific wavelengths of light, produced by LEDs (Light
4
emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm), in the blue light regions of the light spectrum (417±10mm), yellow
light area (590 ± 10nm) and infrared light region of light spectrum (835±15nm).
The LED Light Therapy Device instrument is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, blue light, yellow light); RBI irradiator has five panels, each panel emits three different colors of light sources (red light, blue light, infrared light).
5.2 Composition : The instrument is mainly composed of a main frame, an irradiator, and a lifting stand.
5.3 Equipment functions:
- Light source is extensible according to the areas to be treated to realize large-area irradiation.
- Light source is arranged in matrix, making it more suitable for facial treatment.
- Fixing and electrical connection of the light source is realized through a quick connector, making the replacement more convenient and fast.
- Design of free-lifting cantilever allows the light source to stay at any position and angle.
- 10.4" touch screen simplifies the operation and eliminates the need for professional training.
- 5 commonly used treatment schemes can be stored to avoid repeated setting.
- Warm voice guide makes it easy for you to operate.
- Effective irradiance of the light source can be adjusted according to the treatment need.
- Double switch protection of power switch and power-on password, no need to worry about being misused.
- Non-invasive operation, no damage to skin cells.
- No special care is required after treatment, and makeup can be applied normally.
5.4 Instrument type:
Protection against electric shock: Class I.
Operating mode: continuous operation.
An enclosed apparatus that is not protected against liquid ingress.
Equipment that cannot be used in the presence of flammable anesthetic gas mixed with air or with oxygen or nitrous oxide.
5.5 Main performance indicators
Power supply: AC 100-240V±10%, 50/60 Hz土2% Input power: 600V A Fuse specification, model & rating:T8.0AL/250V Φ5*20 Structure: wheeled Display mode: LCD display Effective irradiation area: 900cm2 ± 10% Irradiation distance: 6cm±1cm Spectral peak wavelength: Red light: 633 nm士 10 nm; Blue light: 417 nm±10 nm;
5
Yellow light: 590 nm±10 nm;
Infrared: 835nm±15nm.
Effective irradiance: The error between the effective irradiance and the nominal value indicated in the nameplate shall be no more than ±25%, and the effective irradiance shall be not more than 200mW/cm2.
Red light: 20~96mW/cm2;
Blue light: 10~120mW/cm2;
Yellow light: 5~35mW/cm2;
Infrared ≤ 70mW/cm2.
Red/IR: 20~166mW/cm²,
Blue/IR: 10~190mW/cm²
Working noise:
Under normal working conditions, the noise generated by the instrument shall not exceed 60dB (A).
Stand adjustment:
Under normal working condition, the stand can be adjusted up, down, left and right, and the irradiator can be fixed at any angle.
Timing and functions
The device has a timer with an error not greater than ±2% of the set value, Continuous working time ≤ 99min;
The function of manually stopping radiation output can be realized through the software pause and stop buttons.
Replaceable irradiator.
Treatment can be preset.
The instrument has a calibration function.
The instrument has a time mode.
The instrument has a dose mode.
The instrument has two functions of continuous output and pulse output.
| No. | Name | Quantity | Unit |
|---|---|---|---|
| 1 | Main frame | 1 | Unit |
| 2 | Irradiator (Irradiator BRY or Irradiator BRI for option) | 2 | Pcs |
| 3 | Protective goggles (for doctors, patients) | 2 | Pieces |
| 4 | Power cord | 1 | Pcs. |
| 5 | Fuse | 2 | Pcs. |
| 6 | Tools (hex wrench (8mm, 4mm, 5mm and 2mm) and | ||
| screwdriver, 1 for each) | 1 | Set | |
| 7 | M3*10 screw | 4 | Pcs. |
| 8 | M6*15 hexagon socket head cap screw | 6 | Pcs. |
| 9 | Upper hole plug, lower hole plug, seal plug | 2 for each | Pcs. |
| 10 | Instructions for Use | 1 | Copy |
5.6 The list of accessories
6
| 11 | Certificate of Conformity | 1 | Copy |
|---|---|---|---|
| ---- | --------------------------- | --- | ------ |
6. Intended Use of Device
LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (599±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
7
7. Summary of Substantial Equivalence
| Proposed Device | Predicate device | Predicate device | Comparison | |
|---|---|---|---|---|
| 510k Number | K222751 | K190938 | K200104 | ------ |
| Product Code | GEX | GEX | GEX | Same |
| Proprietary Name | LED Light Therapy Device | Phototherapy System | Oxylight | ------- |
| Model | KN-7000L | HS-770 | / | ------- |
| Manufacturer | Xuzhou Kernel Medical Equipment Co., Ltd. | Shanghai Apolo Medical Technology Co., Ltd. | RAJA Trading Company, Inc. | ------ |
| Indications for Use | LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light(633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light(417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne | Phototherapy Systems use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris The red light (630nm wavelength) is generally indicated to treatment of superficial, benign vascular, | The Oxylight is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for: -Blue LED – 465nm – to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions. -Yellow LED 590nm - treatment of periorbital | Same |
| vulgaris. | and pigmented lesions | wrinkles and rhytides. | ||
| The Yellow light(599±10nm | ||||
| wavelength)is | ||||
| generally | ||||
| indicated to treat | ||||
| dermatological conditions and | ||||
| specifically indicated for | ||||
| treatment of periorbital | ||||
| wrinkles and rhytides. | ||||
| The infrared light (835±15nm | ||||
| wavelength)is generally use | ||||
| for the temporary relief of | ||||
| minor muscle and joint pain, | ||||
| arthritis and muscle spasm; | ||||
| relieving stiffness; promoting | ||||
| the relaxation of muscle | ||||
| tissue; and to temporarily | ||||
| increase local blood | ||||
| circulation where applied. | The infrared light (835nm | |||
| wavelength) is generally use | ||||
| for the temporary relief of | ||||
| minor muscle and joint pain, | ||||
| arthritis and muscle spasm; | ||||
| relieving stiffness; promoting | ||||
| the relaxation of muscle | ||||
| tissue; and to temporarily | ||||
| increase local blood | ||||
| circulation where applied. | ||||
| Wavelength(s) | ||||
| (nm) | RBY irradiator : (Red light | |||
| 633 ± 10nm, blue light 417 ± | ||||
| 10nm, yellow light 590 ± | ||||
| 10nm). | ||||
| RBI irradiator: (Red 633 ± | ||||
| 10nm, blue 417 ± 10nm, | ||||
| infrared 835 ± 15nm) | Red light 630 ± 15nm | |||
| Blue light 415 ± 15nm | ||||
| Infrared 835 ± 15nm | Red light 625nm | |||
| Blue light 465nm | ||||
| Yellow light 590nm | Substantially equivalent | |||
| Kn-7000L Wavelength(s) | ||||
| is basically the same as | ||||
| K190938 and K200104. | ||||
| Panels Type | RBY Irradiator has 5 panels: | |||
| Red light:465EA LEDs; | ||||
| blue light: 470EA LEDS; | 3 panel: 180EA LEDS | |||
| 4 Panel: 240 EA LEDs. | ||||
| The panels may emit the three | Three type, each head type | |||
| has | ||||
| only one light. | Substantially equivalent | |||
| Kn-7000L Panels Type | ||||
| is basically the same as | ||||
| yellow light: 465EA LEDs; | ||||
| RBI irradiator: has 5 panels: | ||||
| Red light:465EA LEDs; | ||||
| blue light: 470EA LEDs; | ||||
| infrared: 465EA LEDs; | ||||
| The panels may emit the three | ||||
| light (red, blue infrared) | ||||
| individual or in combination | light (red, blue, infrared) | |||
| individual or in combination | Red, Blue, yellow. | K190938 and K200104. | ||
| Output Power | individual or in combination. | |||
| Each panel has three different | ||||
| kinds of light-emitting diodes, | ||||
| and the energy power of the | ||||
| diode is 0.5W | Each LED lamp bead has 4 | |||
| diodes that emit different | ||||
| colors, the energy power of a | ||||
| diode is 3W. | unknown | The Output Power of the | ||
| proposed device is different | ||||
| from the subject predicate | ||||
| K190938. | ||||
| The | ||||
| proposed | ||||
| device has passed the safety | ||||
| test. This difference will not | ||||
| improve | ||||
| the | ||||
| safety | ||||
| and | ||||
| effectiveness of the proposed | ||||
| device. | ||||
| Maximum power | ||||
| density in mW | ||||
| (mW/CM²) | Red light: 20~96 mW/cm2 | |||
| Blue light: 10~120 mW/cm2 | ||||
| Yellow light: 5~35 mW/cm2 | ||||
| Infrared: ≤ 70 mW/cm2 | ||||
| Red/IR: 166mW/cm2, | ||||
| Blue/IR: 190mW/cm2 | (1) Red light: 115mW/cm2, | |||
| (2) Blue light: 120mW/cm2, | ||||
| (3) IR: 70mW/cm2, | ||||
| (4) Red/IR: 120mW/cm2, | ||||
| (5) Blue/IR: 150mW/cm2. | (1) Red: 100mW/cm2 | |||
| (2) Blue: 45mW/cm2 | ||||
| (3) Yellow 35W/cm2 | Substantially equivalent | |||
| Substantially | ||||
| equivalent-within size ranges | ||||
| of predicate devices. | ||||
| Standard does in | ||||
| Joules | Red light: 155J/cm2, | |||
| blue light: 144J/cm2, | ||||
| Yellow light: 42J/cm2, | ||||
| IR: 84J/cm2, | ||||
| Red/IR: 199J/cm2 | (1) Red light: 138J/cm2, | |||
| (2) blue light: 144J/cm2, | ||||
| (3) IR: 84J/cm2, | ||||
| (4) Red/IR: 144J/cm2 | ||||
| (5) Blue/IR: 180J/cm2 | (1) Red: 120J/cm2 | |||
| (2) Blue: 54J/cm2 | ||||
| (3) Yellow: 42J/cm2 | Substantially equivalent | |||
| Substantially | ||||
| equivalent-within size ranges | ||||
| of predicate devices. | ||||
| Blue/IR: 228J/cm2 | ||||
| Adjustable dose | ||||
| range | Red light: 20~96 J/cm2 | |||
| Blue light: 10~120 J/cm2 ² | ||||
| Yellow light: 5~35 J/cm2 | ||||
| Infrared: ≤ 70 J/cm2 | ||||
| Red/IR: 20~166 J/cm2, | ||||
| Blue/IR: 10~190 J/cm2 | (1) Red light: 1-242J/cm2, | |||
| (2) blue light: 1-180J/cm2, | ||||
| (3) IR:1-147J/cm2, | ||||
| (4) Red/IR: 1-144J/cm2, | ||||
| (5) Blue/IR:1-180J/cm2 | (1) Red light: 1-240J/cm2, | |||
| (2) blue light: 1-108J/cm2, | ||||
| (3) Yellow IR:1-84J/cm2, | Substantially equivalent | |||
| Substantially | ||||
| equivalent-within size ranges | ||||
| of predicate devices. | ||||
| Numbers of LEDs | Red light:465EA LEDs; | |||
| Blue light: 470EA LEDs; | ||||
| Yellow light: 465EA LEDs; | ||||
| Infrared: 465EA LEDs; | 3 panels: 180EA, | |||
| 4 panels: 240EA | unknown | Substantially equivalent | ||
| Substantially | ||||
| equivalent-within size ranges | ||||
| of predicate devices. | ||||
| Effective irradiation | ||||
| area: (CM²) | 900 cm² ±10% | 756cm2 and 1008cm2 | 500cm² and 860cm² | Substantially |
| equivalent-within size ranges | ||||
| of predicate devices. | ||||
| Structural style | Wheeled | Wheeled | Wheeled | Same |
| Structure composition | Main frame, irradiator, lifting | |||
| frame. | Main frame, irradiator, lifting | |||
| frame | Irradiator and support | Same | ||
| Power supply | AC 100-240V 50/60Hz | AC 100-240V 50/60Hz 10A | AC 100-240V 50/60Hz | Same |
| Treatment time | 20min | |||
| (Recommended | ||||
| treatment time) | 20min | |||
| (Recommended | ||||
| treatment time) | 20min | |||
| (Recommended | ||||
| treatment time) | Same | |||
| Operation interface | Display Screen | Display Screen | Display Screen | Same |
| Software | Yes | Yes | Yes | Same |
| Safety classification | Class I | Class I | Class I | Same |
| Standard | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-2-57 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-2-57 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-2-57 | Same | |||
| All | ||||
| devices | ||||
| meet | ||||
| the | ||||
| requirements of effectiveness | ||||
| IEC 62471 | IEC 62471 | IEC 62471 | safety. |
Table 1 Comparison to Predicate Device for KN-7000L
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8. Substantial Equivalence discussion:
The indication for use of the KN-7000L LED Light Therapy Device are the same as that for the precifications of the KN-7000L LED Light Therapy Device are either the same or substantially equivalent as compared to the predicate devices. There are no technological differences that raise new or different questions of safety or effectiveness.
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9. Non-Clinical Tests Performed:
Electrical Safety and Electromagnetic Compatibility Testing - KN-7000L LED Light therapy equipment has been tested and meets the following standard requirements of medical equipment:
● IEC60601-1: 2005+2005+CORR.1:2006+CORR.2:2007+A1:2012 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 60601-2-57:2011 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-7000L 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. Conclusion:
Based on comparing to predicate device, the proposed device of KN-7000L are determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.
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