(106 days)
KFB290, KFB291:
Red light: Treatment of full-face wrinkles.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.
KFB265, KFB293:
Red+Infrared Light: Treatment of wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Amber light: Treatment of wrinkles.
KFB290, KFB291:
LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm).
KFB 265, KFB 293:
LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).
This section provides information about the acceptance criteria and the study that proves the device meets those criteria for the LED Light Therapy Device (Models: KFB290, KFB291, KFB265, KFB293).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document details non-clinical performance data (biocompatibility, electrical safety, eye safety, and software verification/validation) and structural equivalence to predicate devices, rather than specific quantitative acceptance criteria for therapeutic efficacy tied to a clinical study. The device is cleared based on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for the stated indications.
The acceptance criteria here are implicitly met by demonstrating compliance with recognized standards and similarity to legally marketed devices.
| Acceptance Criteria Category | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility | Compliance with ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation). All body-contacting materials passed these tests. |
| Electrical Safety | Compliance with: - IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance) - IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances) - IEC 60601-1-11:2015+A1:2020 (Home healthcare environment) - IEC 60601-2-83:2019+A1:2022 (Home light therapy equipment) - IEC 60601-2-57:2011 (Non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) - IEC 62133-2:2017 (Secondary cells and batteries safety) |
| Eye Safety | Compliance with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). |
| Software Verification and Validation | Consistent with a moderate level of concern. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Technological Characteristics and Intended Use | Demonstrated to have the same intended use and similar technological characteristics, features, specifications, and materials as legally marketed predicate devices (K223544, K230351, K162489, K221151). Minor differences do not raise safety or efficacy issues. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes non-clinical performance data and a comparison to predicate devices, not clinical studies with human test sets. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The evaluation relies on standardized testing (e.g., ISO, IEC) and technical comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as the submission focuses on non-clinical performance and substantial equivalence based on technical comparisons and compliance with recognized standards, rather than a clinical study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
An MRMC comparative effectiveness study was not conducted or described in the provided document. The device is an LED Light Therapy Device, not an AI-assisted diagnostic or interpretable imaging device for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A "standalone" performance evaluation in the context of an algorithm or AI was not performed or described. This device is a direct-use LED therapy device.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- Compliance with recognized international standards: (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and medical device safety, IEC 62471 for photobiological safety).
- Substantial equivalence to legally marketed predicate devices: The predicate devices themselves have established a safety and effectiveness profile for the indications.
There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing ground truth regarding therapeutic efficacy for this submission.
8. The Sample Size for the Training Set:
This information is not applicable as the submission is for a phototherapy device, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2024
Dongguan Boyuan Intelligent Technology Co., Ltd. % Jilan Luo RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong Province 518052 China
Re: K241857
Trade/Device Name: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, OLP, ILY Dated: June 26, 2024 Received: June 27, 2024
Dear Jilan Luo:
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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/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
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by TANISHA TANISHA I HITHE -L. HITHE -S Date: 2024.10.11
15:27:56 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241857
Device Name
LED Light Therapy Device(Model(s): KFB290, KFB291, KFB265, KFB293)
Indications for Use (Describe)
KFB290, KFB291:
Red light: Treatment of full-face wrinkles.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.
KFB265, KFB293:
Red+Infrared Light: Treatment of wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Amber light: Treatment of wrinkles.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Company name: Dongguan Boyuan Intelligent Technology Co.,Ltd Address: Room 801, Building 3, No.3 Kuiqiao Road, Puxin Lake, Tangxia Town, Dongguan, Guangdong, China.
Contact person: Le Li Title: Deputy general manager Tel: +86-177 2259 0830 E-mail: 978953150@gq.com Preparation date: September 24, 2024
II. Subject Device
Name of Device: LED Light Therapy Device Model(s): KFB290, KFB291, KFB 265, KFB 293 Common or Usual Name: Light based over the counter wrinkle reduction Over-The-Counter Powered Light Based Laser For Acne Lamp, Infrared, Therapeutic Heating Regulation Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology Infrared lamp. Regulatory Class: II Product Code: OHS, OLP, ILY Regulation Number: 878.4810, 890.5500
III. Predicate and reference Devices
For KFB290, KFB291:
| No. | Manufacturer | Device name | Product code | 510(k) Number |
|---|---|---|---|---|
| 1. | Guangdong NewdermoBiotech Co.,Ltd | LED light therapymask | OHS, OLP, ILY | K223544 |
| 2. | Shenzhen Kaiyan MedicalEquipment Co., Ltd. | LED Facial Mask | OHS, OLP | K230351 |
| 3. | Zhongshan Bisen PlasticElectronic Products Co., Ltd. | RED Light Device | OHS | K162489 |
For KFB 265, KFB 293:
| No. | Manufacturer | Device name | Product code | 510(k) Number |
|---|---|---|---|---|
| 1. | Hunan GuangyeBiotechnology Co., Ltd. | Beauty LED Mask | OHS, OLP | K221151 |
| 2. | Shenzhen Kaiyan MedicalEquipment Co., Ltd. | LED Facial Mask | OHS, OLP | K230351 |
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IV. Device Description KFB290, KFB291:
LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm).
KFB 265, KFB 293:
LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).
V. Indications for Use
KFB290, KFB291:
- Red light: Treatment of full-face wrinkles. a.
- Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and b. muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
- Red+Infrared Light: Treatment of full-face wrinkles. C.
- Amber light: Treatment of full-face wrinkles. d.
- e. Blue light: Treatment of mild to moderate inflammatory acne.
- f. Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.
KFB265, KFB293:
- Red+Infrared Light: Treatment of wrinkles. a.
- b. Blue light: Treatment of mild to moderate inflammatory acne.
- Amber light: Treatment of wrinkles. C.
VI. Comparison of Technological Characteristics With the Predicate Device
The LED Light Therapy Device has the same intended use as the predicates. The technological characteristics, features, specifications, materials are similar to the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use.
Therefore, the LED Light Therapy Device may be found substantially equivalent to its predicate devices.
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| ComparisonElements | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 |
|---|---|---|---|---|
| 510(k) Number | Pending | K223544 | K230351 | K162489 |
| Trade name | LED Light TherapyDevice(Models:KFB290, KFB291) | LED light therapymask, Models: FM-01,FM-02, FM-03 | LED Facial Mask,Model(s): MZ-01,NEWKEY-01, SP-FM-01 | RED Light Device |
| Manufacturer | Dongguan BoyuanIntelligent TechnologyCo.,Ltd | Guangdong NewdermoBiotech Co.,Ltd | Shenzhen KaiyanMedical EquipmentCo., Ltd. | Zhongshan BisenPlastic ElectronicProducts Co., Ltd. |
| Regulation number | 21 CFR 878.481021 CFR 890.5500 | 21 CFR 878.481021 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Classification Name | Light Based Over TheCounter WrinkleReduction(OHS),Over-The-CounterPowered Light BasedLaser For Acne(OLP),Infrared TherapeuticHeating(ILY) | Light Based Over TheCounter WrinkleReduction(OHS),Over-The-CounterPowered Light BasedLaser For Acne(OLP),Infrared TherapeuticHeating(ILY) | Light Based Over TheCounter Wrinkleand Acne Reduction | Light Based Over TheCounter WrinkleReduction |
| Product code | OHS, OLP, ILY | OHS, OLP, ILY | OHS, OLP | OHS |
| Device classification | Class II | Class II | Class II | Class II |
| Indication for use/Intended use | - Red light: Treatmentof full-face wrinkles.- Infrared light: Providetopical heating for thepurpose of elevatingtissue temperature;arthritis and musclespasm; relievingstiffness; promoting therelaxation of muscletissue; and totemporarily increaselocal blood circulation.- Red+Infrared Light:Treatment of full-facewrinkles.- Amber light:Treatment of full-facewrinkles.- Blue light: Treatmentof mild to moderateinflammatory acne. | Red light: Treatment offull-face wrinkles.Blue light: Treatment ofmild to moderateinflammatory acne.Infrared light: Providetopical heating for thepurpose of elevatingtissue temperature;arthritis and musclespasm; relievingstiffness; promoting therelaxation of muscletissue; and totemporarily increaselocal blood circulation.Mixed light:Treatmentof mild to moderateinflammatory acne. | LED Facial Mask is anover the counter devicethat is intended to useLED light for thetreatment of wrinklesand mild to moderateacne. | The RED Light Deviceis an OTC deviceindicated to emit energyin the red and IR regionof the spectrum for usein dermatology for thetreatment of periorbitalwrinkles. |
| - Mixed light(Red+Blue+Infrared): Treatmentof mild to moderateinflammatory acne. | ||||
| Prescription or OTC | OTC | OTC | OTC | OTC |
| Dimension | KFB290:Approximately 302mm x 197 mm x 22mmKFB291:Approximately 412mm x 195 mm x 22mm | FM-01: 207 * 277 * 43 mm,FM-02: 198 * 383 * 33.5 mm,FM-03: 237.5 * 108 * 8.1 mm | / | / |
| Power supply | Input: 100 -240 V, 50 /60 HzOutput: 5V, 1ALithium ion battery:1300mAh | Input: 100-240V,50/60Hz, 0.25 AOutput: DC 5 V, 500 mA | An external adapterInput: AC 100-240V50-60Hz 0.2AOutput: DC 12V 0.5A | Adaptor:100~240V AC50/60Hz Lithiumbattery: 2x3.7V |
| Sterilization | Not applicable | Not applicable | Not applicable | Not applicable |
| Light source | Light Emitting Diodes | Light Emitting Diodes | Light Emitting Diodes | Light Emitting Diodes |
| Location for use | Face | Face and body | Face | Face |
| Wavelength | 635nm ± 5nm visiblered light;850nm±5nm Invisiblered light;465 ± 5nm blue light;605 ± 5nm amber light | Red: 620nmBlue: 460nmInfrared: 850nmMixed: 620nm and850nm and 460nm | Blue: 465nm±5nmRed: 625nm±5nmAmber: 605nm±5nm | Red: 633nm ±5nmvisible red light;Infrared: 830nm±5nmInvisible red light; |
| Irradiance | Red: 25mW/cm²;IR: 3mW/cm²;Red+IR: 30mW/cm²;Blue: 18mW/cm²;Amber: 20mW/cm²;Mixed light:9mW/cm²; | Red light:2.0 | Blue: 15 | 125 mW/cm²70 mW/cm² (633 nm)55 mW/cm² (830 nm) |
| Treatment time | For red, blue andred+infrared: 10, 20,30 minutesFor infrared, amberlight and mixed light:10, 20 minutes. | Manual Mode: 15minutes each time,Automatic Mode: 10minutes each time. | 10 minutes/day,3 times per week | 15-20 minutes |
| Compliancewithvoluntary standards | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-11;IEC 60601-2-83;IEC 62471 | IEC 60601-1;IEC 60601-1-2 | IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-57IEC62471 | IEC60601-1-2IEC60601-1IEC60601-1-11IEC60601-2-57IEC62471 |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | Comply with ISO 10993-1, ISO 10993-5 and ISO 10993-10 | ISO 10993-1 |
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Table2: Substantial Equivalence Comparison for KFB265, KFB293
| Comparison Elements | Subject Device | Predicate Device | Reference Device 1 |
|---|---|---|---|
| 510(k) Number | Pending | K221151 | K230351 |
| Trade name | LED Light TherapyDevice(Models: KFB 265,KFB 293) | Beauty LED Mask, Model:KFB 265 | LED Facial Mask, Model(s):MZ-01, NEWKEY-01, SP-FM-01 |
| Manufacturer | Dongguan Boyuan IntelligentTechnology Co.,Ltd | Hunan GuangyeBiotechnology Co., Ltd. | Shenzhen Kaiyan MedicalEquipment Co., Ltd. |
| Regulation number | 21 CFR 878.481021 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Classification Name | Light Based Over The CounterWrinkle Reduction(OHS),Over-The-Counter PoweredLight Based Laser ForAcne(OLP), InfraredTherapeutic Heating(ILY) | Light Based Over TheCounter Wrinkle and AcneReduction | Light Based Over The CounterWrinkle and Acne Reduction |
| Product code | OHS, OLP, ILY | OHS, OLP | OHS, OLP |
| Device classification | Class II | Class II | Class II |
| Indicationfor use/Intended use | - Red+Infrared Light:Treatment of wrinkles.- Blue light: Treatment of mildto moderate inflammatoryacne.- Amber light: Treatment ofwrinkles. | The device is intended to useLED light for the treatment ofwrinkles and mild to moderateacne. | LED Facial Mask is an overthe counter device that isintended to use LED light forthe treatment of wrinkles andmild to moderate acne. |
| Prescription or OTC | OTC | OTC | OTC |
| Dimension | KFB 265: Approximately183 mm x 238 mm x 98 mmKFB 293: Approximately228.3 mm x 139.5 mm x 90mmController: 100mm x 50mm x 21.5 mm | LED Mask: Approximately183 * 238 * 98 mmController: 100 * 50 * 21.5mm | / |
| Power supply | Input: 100 -240 V, 50 / 60 HzOutput: 5V, 1ALithium ion battery:1300mAh | Input: 100 -240 V ~ 50 /60 HzOutput: 5V 1A | An external adapter Input: AC100-240V 50-60Hz 0.2AOutput: DC 12V 0.5A |
| Comparison Elements | Subject Device | Predicate Device | Reference Device 1 |
| 510(k) Number | Pending | K221151 | K230351 |
| Sterilization | Not applicable | Not applicable | Not applicable |
| Light source | Light Emitting Diodes | Light Emitting Diodes | Light Emitting Diodes |
| Location for use | Face | Face | Face |
| Wavelength | visible red light: 637nm ±5nm;invisible red light: 854nm ±5nm;blue light: 465±5nm;amber light: 605 ± 5nm; | Red (637nm±5nm) andIR (854nm±5nm);Blue (465±5nm) | Blue: 465nm±5nmRed: 625nm±5nmAmber: 605nm±5nm |
| Irradiance | Red+IR: 25.5mW/cm²Blue: 1.36mW/cm²Amber: 20mW/cm² | Red+IR: 25.5mW/cm²Blue: 1.36mW/cm² | Blue: 15 |
| Treatment time | 10 minutes | 10 min | 10 minutes/day,3 times per week |
| Compliancewithvoluntary standards | IEC 60601-1; | IEC 60601-1; | IEC60601-1-2 |
| IEC 60601-1-2;IEC 60601-1-11;IEC 60601-2-57;IEC 62471 | IEC 60601-1-2;IEC 60601-1-11;IEC 60601-2-57;IEC 62471 | IEC 60601-1IEC60601-1-11IEC60601-2-57IEC62471 | |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | Allbody-contactingmaterials are complied withISO10993-5 and ISO 10993-10 | Comply with ISO 10993-1,ISO 10993-5 and ISO 10993-10 |
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VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the LED Light Therapy Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5: 2009, Biological evaluation of medical devices -Par t 5: Tests for in vitro cytotoxicity
-
ISO 10993-10: 2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
-
ISO 10993-23: 2021, Biological evaluation of medical devices Part 23: Tests for irritation
2) Electrical Safety
- IEC 60601-1: 2005+A1:2012+A2:2020 Medical electrical equipment Part 1: General requirements A for basic safety and essential performance
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- A IEC 60601-1-2:2014+A1:2020 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1-11: 2015+A1:2020 Medical Electrical Equipment -Part 1-11: General Requirements A for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- A IEC 60601-2-83: 2019+A1:2022 - Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
-
IEC 60601-2-57: 2011 - MEDICAL ELECTRICAL EQUIPMENT- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic,monitoring and cosmetic/aesthetic use
-
IEC 62133-2: 2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
3) Eye Safety
-
IEC 62471: 2006 Photobiological safety of lamps and lamp systems
4) 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.
VIII. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 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.