(106 days)
No
The summary describes a device that uses LED light therapy at specific wavelengths for various skin treatments. There is no mention of AI, ML, image processing, or any data-driven decision-making process within the device's operation. The performance studies focus on safety and electrical standards, not algorithmic performance.
Yes
The device is described as treating conditions such as wrinkles, arthritis, muscle spasms, stiffness, and inflammatory acne, which are all medical conditions, indicating a therapeutic intent. Additionally, it is said to "elevate tissue temperature for the purpose of elevating tissue temperature," "relieving stiffness," "promoting the relaxation of muscle tissue," and "temporarily increase local blood circulation," all of which imply therapeutic effects.
No
The device is a light therapy device intended for treatment of wrinkles, acne, and providing topical heating, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a "main unit (mask), controller, Silicone eye protector, USB charging cable and straps" or "main unit (mask), controller, USB charging cable and adapter," which are physical hardware components. The software verification and validation mentioned are for the software controlling these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are for therapeutic purposes (treating wrinkles, acne, muscle issues, increasing blood circulation) using light therapy. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a wearable LED phototherapy device that applies light to the skin. This is a physical therapy/treatment device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on such analysis.
The device falls under the category of a therapeutic medical device, specifically a light therapy device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP, ILY
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
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)
The following performance data were provided in support of the substantial equivalence determination.
- 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
- Electrical Safety:
- IEC 60601-1: 2005+A1:2012+A2:2020 Medical electrical equipment Part 1: General requirements A for basic safety and essential performance
- 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
- Eye Safety:
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems
- 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.
Key Results: 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.
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.
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 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).
2
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
3
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)
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."
4
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 Newdermo | |||
| Biotech Co.,Ltd | LED light therapy | |||
| mask | OHS, OLP, ILY | K223544 | ||
| 2. | Shenzhen Kaiyan Medical | |||
| Equipment Co., Ltd. | LED Facial Mask | OHS, OLP | K230351 | |
| 3. | Zhongshan Bisen Plastic | |||
| Electronic Products Co., Ltd. | RED Light Device | OHS | K162489 |
For KFB 265, KFB 293:
| No. | Manufacturer | Device name | Product code | 510(k) Number |
|---|---|---|---|---|
| 1. | Hunan Guangye | |||
| Biotechnology Co., Ltd. | Beauty LED Mask | OHS, OLP | K221151 | |
| 2. | Shenzhen Kaiyan Medical | |||
| Equipment Co., Ltd. | LED Facial Mask | OHS, OLP | K230351 |
5
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.
6
| Comparison
| Elements | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 |
|---|---|---|---|---|
| 510(k) Number | Pending | K223544 | K230351 | K162489 |
| Trade name | LED Light Therapy | |||
| Device(Models: | ||||
| KFB290, KFB291) | LED light therapy | |||
| mask, Models: FM-01, | ||||
| FM-02, FM-03 | LED Facial Mask, | |||
| Model(s): MZ-01, | ||||
| NEWKEY-01, SP- | ||||
| FM-01 | RED Light Device | |||
| Manufacturer | Dongguan Boyuan | |||
| Intelligent Technology | ||||
| Co.,Ltd | Guangdong Newdermo | |||
| Biotech Co.,Ltd | Shenzhen Kaiyan | |||
| Medical Equipment | ||||
| Co., Ltd. | Zhongshan Bisen | |||
| Plastic Electronic | ||||
| Products Co., Ltd. | ||||
| Regulation number | 21 CFR 878.4810 | |||
| 21 CFR 890.5500 | 21 CFR 878.4810 | |||
| 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | ||
| Classification Name | Light Based Over The | |||
| Counter Wrinkle | ||||
| Reduction(OHS), | ||||
| Over-The-Counter | ||||
| Powered Light Based | ||||
| Laser For Acne(OLP), | ||||
| Infrared Therapeutic | ||||
| Heating(ILY) | Light Based Over The | |||
| Counter Wrinkle | ||||
| Reduction(OHS), | ||||
| Over-The-Counter | ||||
| Powered Light Based | ||||
| Laser For Acne(OLP), | ||||
| Infrared Therapeutic | ||||
| Heating(ILY) | Light Based Over The | |||
| Counter Wrinkle | ||||
| and Acne Reduction | Light Based Over The | |||
| Counter Wrinkle | ||||
| Reduction | ||||
| 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: 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. | Red light: Treatment of
full-face wrinkles.
Blue light: Treatment of
mild to moderate
inflammatory acne.
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.
Mixed light:Treatment
of mild to moderate
inflammatory acne. | LED Facial Mask is an
over the counter device
that is intended to use
LED light for the
treatment of wrinkles
and mild to moderate
acne. | The RED Light Device
is an OTC device
indicated to emit energy
in the red and IR region
of the spectrum for use
in dermatology for the
treatment of periorbital
wrinkles. |
| - Mixed light(Red+Blue
+Infrared): Treatment
of mild to moderate
inflammatory acne. | | | | |
| Prescription or OTC | OTC | OTC | OTC | OTC |
| Dimension | KFB290:
Approximately 302
mm x 197 mm x 22
mm
KFB291:
Approximately 412
mm x 195 mm x 22
mm | 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 Hz
Output: 5V, 1A
Lithium ion battery:
1300mAh | Input: 100-240V,
50/60Hz, 0.25 A
Output: DC 5 V, 500 mA | An external adapter
Input: AC 100-240V
50-60Hz 0.2A
Output: DC 12V 0.5A | Adaptor:100240V AC3.0mW/cm²
50/60Hz Lithium
battery: 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 visible
red light;
850nm±5nm Invisible
red light;
465 ± 5nm blue light;
605 ± 5nm amber light | Red: 620nm
Blue: 460nm
Infrared: 850nm
Mixed: 620nm and
850nm and 460nm | Blue: 465nm±5nm
Red: 625nm±5nm
Amber: 605nm±5nm | Red: 633nm ±5nm
visible red light;
Infrared: 830nm±5nm
Invisible 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 light:
2.04.0mW/cm²4.0
Infrared light: 2.0
mW/cm²
Mixed light: 9.012.063mW/cm²
mW/cm² | Blue: 15
Red: 3175mW/cm²42mW/cm² | 125 mW/cm²
Amber:
15
70 mW/cm² (633 nm)
55 mW/cm² (830 nm) |
| Treatment time | For red, blue and
red+infrared: 10, 20,
30 minutes
For infrared, amber
light and mixed light:
10, 20 minutes. | Manual Mode: 15
minutes each time,
Automatic Mode: 10
minutes each time. | 10 minutes/day,
3 times per week | 15-20 minutes |
| Compliance
with
voluntary 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 | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-57
IEC62471 | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-57
IEC62471 |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 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 |
7
8
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 Therapy | ||
| Device(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 Intelligent | ||
| Technology Co.,Ltd | Hunan Guangye | ||
| Biotechnology Co., Ltd. | Shenzhen Kaiyan Medical | ||
| Equipment Co., Ltd. | |||
| Regulation number | 21 CFR 878.4810 | ||
| 21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | |
| Classification Name | Light Based Over The Counter | ||
| Wrinkle Reduction(OHS), | |||
| Over-The-Counter Powered | |||
| Light Based Laser For | |||
| Acne(OLP), Infrared | |||
| Therapeutic Heating(ILY) | Light Based Over The | ||
| Counter Wrinkle and Acne | |||
| Reduction | Light Based Over The Counter | ||
| Wrinkle and Acne Reduction | |||
| Product code | OHS, OLP, ILY | OHS, OLP | OHS, OLP |
| Device classification | Class II | Class II | Class II |
| Indication | |||
| for use/ | |||
| Intended use | - Red+Infrared Light: | ||
| Treatment of wrinkles. |
- Blue light: Treatment of mild
to moderate inflammatory
acne. - Amber light: Treatment of
wrinkles. | The device is intended to use
LED light for the treatment of
wrinkles and mild to moderate
acne. | LED Facial Mask is an over
the counter device that is
intended to use LED light for
the treatment of wrinkles and
mild to moderate acne. |
| Prescription or OTC | OTC | OTC | OTC |
| Dimension | KFB 265: Approximately
183 mm x 238 mm x 98 mm
KFB 293: Approximately
228.3 mm x 139.5 mm x 90
mm
Controller: 100mm x 50
mm x 21.5 mm | LED Mask: Approximately
183 * 238 * 98 mm
Controller: 100 * 50 * 21.5
mm | / |
| Power supply | Input: 100 -240 V, 50 / 60 Hz
Output: 5V, 1A
Lithium ion battery:
1300mAh | Input: 100 -240 V ~ 50 /60 Hz
Output: 5V 1A | An external adapter Input: AC
100-240V 50-60Hz 0.2A
Output: 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) and
IR (854nm±5nm);
Blue (465±5nm) | Blue: 465nm±5nm
Red: 625nm±5nm
Amber: 605nm±5nm |
| Irradiance | Red+IR: 25.5mW/cm²
Blue: 1.36mW/cm²
Amber: 20mW/cm² | Red+IR: 25.5mW/cm²
Blue: 1.36mW/cm² | Blue: 1563mW/cm²75mW/cm²
Red: 31
Amber: 15~42mW/cm² |
| Treatment time | 10 minutes | 10 min | 10 minutes/day,
3 times per week |
| Compliance
with
voluntary 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 60601-1
IEC60601-1-11
IEC60601-2-57
IEC62471 |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 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 |
9
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
10
- 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.