(238 days)
Red light: Treatment of full- face wrinkles.
Blue light (only suitable model M226 and MN1 LED Facial Mask): 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 full face wrinkles.
The subject device LED Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrowband of light for the treatment of cosmetic indications including facial wrinkles and acnes.
The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and Type-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.
It appears there's a misunderstanding of the provided FDA 510(k) clearance letter. The document is for an LED Therapy Mask, which is a physical device used for cosmetic and therapeutic purposes, not an AI/software-based medical device.
Therefore, the concepts of acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets are not applicable to this type of device submission. These concepts are relevant for AI/ML-driven medical devices that output diagnostic or prognostic information, where the performance of an algorithm needs to be validated against clinical ground truth.
The provided FDA letter and 510(k) summary describe:
- Device Name: LED Therapy Mask (MN1, M226)
- Regulation Number: 21 CFR 878.4810 (Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology)
- Regulatory Class: Class II
- Product Code: OHS, ILY, OLP
- Indications for Use: Treatment of full-face wrinkles (Red/Mixed light), mild to moderate inflammatory acne (Blue light), and providing topical heating for various muscular/joint relief (Infrared light).
- Performance Data: The data provided relates to the physical and electrical safety, biocompatibility, eye safety, software verification & validation (for the device's control software, not AI), and usability of the LED mask itself.
Since the request asks for information about acceptance criteria and studies proving the device meets acceptance criteria, and the provided device is an LED mask (not an AI algorithm), I will interpret "acceptance criteria" based on the documentation provided for this specific device.
Here's an analysis based on the provided document, clarifying that AI/ML specific criteria are not applicable:
Device: LED Therapy Mask (MN1, M226)
Nature of the Device: Physical LED light therapy device for cosmetic and therapeutic applications, primarily using light emission for treatment. It is not an AI/ML algorithm-based diagnostic or prognostic device.
Therefore, the concepts of a "test set" for algorithm performance, "ground truth" for clinical accuracy, "experts" for labeling data, "adjudication," "MRMC studies," "standalone algorithm performance," and "training sets" in the context of AI/ML are NOT APPLICABLE to this device.
The "acceptance criteria" for this device relate to its safety, electrical performance, biocompatibility, and functional integrity as a light-emitting medical device.
Table of Acceptance Criteria and Reported Device Performance (Based on provided document):
| Acceptance Criteria Category | Specific Criteria (Inferred from tests performed) | Reported Device Performance (Summary from document) |
|---|---|---|
| Biocompatibility | - Absence of cytotoxicity | Passed (ISO 10993-5) |
| - Absence of skin sensitization | Passed (ISO 10993-10) | |
| - Absence of skin irritation | Passed (ISO 10993-23) | |
| Electrical Safety & EMC | - Compliance with basic safety and essential performance standards | Passed (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62133-2) |
| - Electromagnetic compatibility | Passed (IEC 60601-1-2) | |
| - Safety of rechargeable lithium battery | Passed (IEC 62133-2) | |
| Eye Safety | - Compliance with photobiological safety standards | Passed (IEC 62471 Photobiological safety of lamps and lamp systems) |
| Software Functionality | - Software verification and validation (for control logic) | All software requirements met, hazards mitigated to acceptable risk levels. Consistent with moderate level of concern. |
| Usability | - Evaluation of product usability | Verified according to FDA guidance (Applying Human Factors and Usability Engineering to Medical Devices) |
| Performance (Light Output) | - Specific Wavelengths & LED Intensity within intended range (compared to predicates) | Wavelengths: Red: 630nm±5nm, Blue: 470 nm±5nm, Near-Infrared: 850 nm±5nm (Similar to predicates).LED Intensity: Red: 0.89 |
Responses to Specific Questions (with clarifications on applicability):
-
A table of acceptance criteria and the reported device performance: See table above. These are the engineering, safety, and performance criteria relevant to a hardware medical device like an LED mask.
-
Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a "test set" for an AI/ML algorithm. The "tests" here refer to standard engineering and biological safety tests on the device's components and system. These typically involve a limited number of device units or material samples. The document does not specify the number of units/samples tested for each battery of tests (e.g., biocompatibility samples, electrical safety units).
- Data Provenance: The tests are standard laboratory/bench testing performed on the physical device and its materials. The document does not specify the country of origin for the test data itself, beyond the manufacturer being based in Shenzhen, China. This is not retrospective or prospective in the clinical AI sense; it's product validation testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. "Ground truth" in the AI/ML sense (e.g., radiologist labels for images) does not apply here. The "ground truth" for this device's performance is established by objective physical measurements (e.g., light output, electrical parameters) and standardized biological test results performed by qualified laboratories, often certified to conduct such tests (e.g., ISO-certified labs).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus "ground truth" from multiple human experts for AI model evaluation. This device is not an AI model requiring such clinical ground truth.
-
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:
- Not Applicable. MRMC studies are specific to evaluating diagnostic AI systems where human readers interpret medical images or data. This device is a direct treatment device, not an interpretative AI.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm. Its "standalone performance" refers to its ability to emit light at specified wavelengths and intensities, which is part of the electrical and performance testing. The "software verification and validation" mentioned is for the device's control software, ensuring it functions correctly, not for an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the AI/ML context. For a physical device, "ground truth" typically refers to:
- Standardized Test Methods: Biocompatibility (ISO 10993 series), Electrical Safety (IEC 60601 series), Photobiological Safety (IEC 62471). These international standards define the acceptable performance and safety limits, which serve as the "ground truth" for compliance.
- Physical Measurements: Wavelengths and intensities of light emitted are physically measured and compared against specifications and predicate devices.
- Not Applicable in the AI/ML context. For a physical device, "ground truth" typically refers to:
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. No training set is used for this device.
FDA 510(k) Clearance Letter - LED Therapy Mask
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 7, 2025
Shenzhen Borria Technology Co., Ltd
Chardy Wang
Project Leader
501, Floor 5, Building 6, Industrial Zone, No.2015, Shenyan Road, Pengwan Community, Haishan Street, Yantian District
Shenzhen,
China
Re: K242385
Trade/Device Name: LED Therapy Mask (MN1, M226)
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, ILY, OLP
Dated: August 12, 2024
Received: August 12, 2024
Dear Chardy Wang:
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 (the 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/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.
Page 2
K242385 - Chardy Wang Page 2
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 (QS) 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 (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-reporting-combination-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 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 Rule"). 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.
Page 3
K242385 - Chardy Wang Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
TANISHA L. HITHE -S Digitally signed by TANISHA L. HITHE -S Date: 2025.04.07 17:08:19 -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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K242385
Device Name: LED Therapy Mask (MN1, M226)
Indications for Use (Describe):
Red light: Treatment of full- face wrinkles.
Blue light (only suitable model M226 and MN1 LED Facial Mask): 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 full face wrinkles.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
SHENZHEN BORRIA TECHNOLOGY CO.,LTD
K242385 –510(k) Summary
510(k) Summary-K242385
"510(k) Summary" as required by 21 CFR Part 807.92.
April 2, 2025
I. Submitter
SHENZHEN BORRIA TECHNOLOGY CO.,LTD
501, Floor 5, Building 6, Industrial Zone, No.2015, Shenyan Road, Pengwan Community, Haishan Street, Yantian District, Shenzhen
Chardy Wang
Project Leader
Tel: +86 133 1290 5505
Email: 466144494@qq.com
II. Device
Name of Device: LED Therapy Mask
Model(s): MN1, M226
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: II
Product Code: OHS, OLP, ILY
Regulation Number: 21 CFR 878.4810
III. Predicate Device and Reference Device
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Guangdong Newdermo Biotech Co., Ltd | LED light therapy mask (FM-01, FM-02, FM-03) | K223544 | Feb 23, 2023 |
Page 6
Reference device 1:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| myBlend | MyLedMask | K223147 | May 14, 2023 |
Reference device 2:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| La Lumiere, LLC | Pro X OTC 5 Light Therapy Device | K140471 | Jan 15, 2025 |
Reference device 3:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Trophy Skin Incorporated | Rejuvalite MD | K133896 | Nov 13, 2014 |
IV. Device Description
The subject device LED Therapy Mask is a home use wearable LED phototherapy device whose purpose is to produce an even and narrowband of light for the treatment of cosmetic indications including facial wrinkles and acnes.
The subject device consists of a mask body unit that contains light emitting diodes (LEDs), a controller, straps and Type-C charging cable. And the device is powered by built-in rechargeable lithium battery on the controller.
Page 7
The LEDs generate 4 kinds of light which include Blue light (460nm, only suitable model M226 and MN1 LED Facial Mask), Red light (630nm), Infrared light (850nm) and Mixed light (630nm and 850nm). A controller is connect to the mask body unit to control the device, such as turn on/off the device, switch LED output. And the straps used for securing the mask unit to the body part.
V. Indications for Use
Red light: Treatment of full- face wrinkles.
Blue light (only suitable model M226 and MN1 LED Facial Mask): 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 full face wrinkles.
VI. Comparison of Technological Characteristics With the Predicate Devices
| Comparison Elements | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| 510(k) Number | Pending | K223544 | K223147 | K140471 | K133896 | / |
| Trade name | LED Therapy Mask (MN1, M226) | LED light therapy mask (FM-01, FM-02, FM-03) | MyLedMask | Pro X OTC 5 Light Therapy Device | Rejuvalite MD | / |
Page 8
| Comparison Elements | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| Manufacturer | SHENZHEN BORRIA TECHNOLOGY CO., LTD | Guangdong Newdermo Biotech Co., Ltd | myBlend | La Lumiere, LLC | Trophy Skin Incorporated | / |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHS, OLP, ILY | OHS, OLP, ILY | OHS | OHS | OHS | |
| Device classification | Class II | Class II | Class II | Class II | Class II | Same |
| Indication for use/ Intended use | Red light: Treatment of full-face wrinkles. Blue light (only suitable model M226 and MN1 LED Facial Mask): 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 | Red light: Treatment of fullface 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 | MyLedMask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of fullface wrinkles | The Pro XOTC 5is an Over-TheCounter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I,II and/or III. | The Rejuvalite MD is an Over the Counter device that is intended for the use in the treatment of full face wrinkles. | Same |
Page 9
| Comparison Elements | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne. | increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne. | |||||
| Indication for use/ Intended use | Red light: Treatment of full-face wrinkles. Blue light (only suitable model M226 and MN1 LED Facial Mask): 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 full face wrinkles. | Red light: Treatment of fullface 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 | MyLedMask is an over-the-counter device that is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of fullface wrinkles | The Pro XOTC 5is an Over-TheCounter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I,II and/or III. | The Rejuvalite MD is an Over the Counter device that is intended for the use in the treatment of full face wrinkles. | Same |
Page 10
| Comparison Elements | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| Location for use | Face and Neck | Face and body | Face and Neck | Full Face | Full Face | Same |
| Prescription or OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Power supply | Input：DC 5V, 1A Built-in rechargeable lithium battery: DC 3.7V 2500mAh | Input: 100-240 V~, 50/60 Hz, 0.25 A Output: DC 5 V, 500 mA | Voltage: 100 to 240 volts, AC Frequency:50-60Hz Intensity: 0.35 A | Unknown | AC to DC | Same |
| Light source | LEDs | LEDs | LEDs | Light-emitting diodes | LEDs | Same |
| Wavelength | Red: 630nm±5nm Blue: 470 nm± 5nm Near-Infrared: 850 nm±5nm | Red: 620nm Blue: 460nm Infrared: 850nm Mixed: 620nm and 850nm and 460nm | Red:630 nm (OSRAM LS T67F) NIR: 850 nm (OSRAM SFH 4253) | Red: 620-640nm IR: 820-880nm | Red 600,622,660nm IR 860nm | Similar Note 1 |
Page 11
| Comparison Elements | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| Mixed light: 630nm and 850nm | ||||||
| LED Intensity | Red: 0.89 | Red light: 2.0 | 18.7 mW/cm² (average of 6 measurement location (including one on the neck) between 10 to 27mW/cm²) | Red light and IR light: 0.76 mW/cm² | Red light and IR light: 2.35 mW/cm² | Similar Note 2 |
| Dimensions (mm) | MN1: LED Facial Mask: 300208.55.5mm LED Neck Mask: 338.5249.75.5mm M226: LED Facial Mask: 300208.55.5mm | FM-01: 207X277X43mm, FM-02: 198X383X33.5mm, FM-03: 237.5X108X8.1mm | LED mask: 176 x342 x 122 Storage case:365 x 225 x150 | Unknown | Unknown | Different Note 3 |
| Treatment Time | 10 minutes each time | Manual Mode: 15minutes each time, Automatic Mode: 10minutes each time | According to skin phototype, daily - 1 fair skin: 5 min 35 (335 s) - 2 moderately dark skin: 11 min 10 (670 s) - 3 dark | 900 seconds | 3 minutes daily, 5 days per week for 8 weeks |
Page 12
| Comparison Elements | Subject Device | Primary Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Remark |
|---|---|---|---|---|---|---|
| skin: 13 min 55 (835 s) during 6 to 8 week | ||||||
| Electrical safety | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-83 IEC 62471 IEC 62133-2 | IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11 IEC 60601-2-57 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-57 | Unknown | IEC 60601-1 IEC 60601-1-2 | Same |
| Biocompatibility feature | All body-contacting materials are complied with ISO 10993-5, ISO 10993-10 and ISO 10993-23 | All body-contacting materials are complied with ISO10993-5 and ISO 10993-10 | Unknown | Unknown | Unknown | Same |
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Evaluation
The biocompatibility evaluation for the body-contacting components of the Intense pulsed light 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:
Page 13
- ISO 10993-5:2009, Biological evaluation of medical devices –Part 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 skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-11 Edition 2.1 2020-07 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-83:2019 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62133-2 Edition1.0 2017-02, 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 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Page 14
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.
5) Usability
The product usability has been evaluated and verified according to the following FDA guidance
- Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016.
VIII. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device LED Therapy Mask is as safe, as effective, and performs as well as the legally marketed predicate device and reference 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.