(88 days)
No
The device description and summary of performance studies do not mention any AI or ML components. The functionality described is based on standard IPL technology with a skin sensor and cooling function.
No
The device is intended for the removal of unwanted hair, which is a cosmetic purpose, not for treating a disease or condition.
No
The device is intended for hair removal and hair reduction, which is a treatment or cosmetic procedure, not for diagnosing a condition or disease.
No
The device description explicitly states it includes hardware components such as an IPL host, power adapter, lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, DC socket, and skin sensor. It is an Intense Pulsed Light (IPL) device, which is a hardware-based technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted body hair and/or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that uses Intense Pulsed Light (IPL) to reduce hair growth. This is a physical treatment applied to the body, not a test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for medical diagnosis.
- Anatomical Site: The device is applied to the skin (body and face), not used to analyze internal samples.
In summary, the Hair Removal Device is a therapeutic or aesthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Product codes
OHT
Device Description
Hair Removal Device (Model: R3C16-P, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
Hair Removal Device includes two series (R3C16 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket.
The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with "Pro" in the model name is equipped with sapphire while the model without "Pro" uses metal treatment window surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Body hair and/or facial hair.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home-use and personal device.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- 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 irritation
- IEC 60601-1: 2020, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2020, Medical electrical equipments for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11: 2020. 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: 2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471: 2006, Photobiological safety of lamps and lamp systems
- IEC 60601-1-6: 2020, Medical electrical equipments for basic safety and essential performance -Collateral standard: Usability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2024
Shenzhen Jianchao Intelligent Technology Co., Ltd. % Riley Chen RA Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K242710
Trade/Device Name: Hair Removal Device (R3C16-P, R3C16-G, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) 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: OHT Dated: September 5, 2024 Received: September 9, 2024
Dear Riley Chen:
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/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 (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 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 (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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yan Fu -S
Digitally signed by Yan Fu
Date: 2024.12.06 13:50:30
-05'00' for 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) K242710
Device Name
Name of Device: Hair Removal Device
Model(s): R3C16-P, R3C16-W, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W. R3505-B, R3505-W Pro, R3505-B Pro
Indications for Use (Describe)
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
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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4
510(k) Summary: K242710
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Shenzhen Jianchao Intelligent Technology Co., Ltd. Rm301, Bldg.25, No.68 Hexiu West Road, Fuhai St., Baoan, Shenzhen, CN Post code: 518107 Fax: +86-0755-86961489
Fred Li Title: Director Tel.: +86 18675507170 Email: fred@vellcolife.com
Date of preparation: 2024-09-06
II. Device
Name of Device: Hair Removal Device
Model(s): R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Device & Reference Device
Predicate device:
| Predicate Device | Manufacturer | 510(k) Number | Product code |
|---|---|---|---|
| Hair | |||
| Removal Device | |||
| (R2815-G Pro, R2815-G) | Shenzhen Jianchao Intelligent | ||
| Technology Co., Ltd. | K232575 | OHT | |
| Ipulse Smoothskin Gold Hair | |||
| Removal Device | Cyden Limited | K160968 | OHT, GEX |
| IPL Hair Removal Device | SHENZHEN BORRIA | ||
| TECHNOLOGY CO., LTD. | K232939 | OHT |
Reference device:
| Reference Device | Manufacturer | 510(k) Number | Product code |
|---|---|---|---|
| IPL Hair Removal Device Joy | |||
| Version (CB-027) | Shen Zhen CosBeauty Co., | ||
| Ltd | K173813 | OHT | |
| iPulse Hair Removal System | CyDen, Ltd. | K130315 | OHT |
5
IV. Device Description
Hair Removal Device (Model: R3C16-P, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
Hair Removal Device includes two series (R3C16 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket.
The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with "Pro" in the model name is equipped with sapphire while the model without "Pro" uses metal treatment window surface. The difference of design between models are listed below:
| Model (s) | Enclosure color | Cooling function | Product drawing |
|---|---|---|---|
| R3C16-P | Purple | Metal cooling | Image: Product drawing 1 |
| R3C16-W | White | Metal cooling | Image: Product drawing 1 |
| R3C16-G | Golden | Metal cooling | Image: Product drawing 1 |
| R3C16-P Pro | Purple | Sapphire cooling | Image: Product drawing 1 |
| R3C16-W Pro | White | Sapphire cooling | Image: Product drawing 1 |
| R3C16-G Pro | Golden | Sapphire cooling | Image: Product drawing 1 |
| R3505-W | White | Metal cooling | Image: Product drawing 2 |
| R3505-B | Black | Metal cooling | Image: Product drawing 2 |
| R3505-W Pro | White | Sapphire cooling | Image: Product drawing 2 |
| R3505-B Pro | Black | Sapphire cooling | Image: Product drawing 2 |
V. Indications for Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Comparison of Indications for Use: The indications for use of the subject device is comparable to the indications for use of the predicate device.
VI. Comparison of Technological Characteristics With the Predicate Device
The Hair Removal Device has the same indications for use, mode of action and similar operational characteristics as 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
6
is safe and as effective as the predicate devices for its intended use. Therefore, the Hair Removal Device may be found substantially equivalent to its predicate devices.
Hair Removal Device is compared with the following predicate devices and reference devices in terms of intended use, design, specifications and performance:
7
| Comparison
| Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate device 3 | Reference Device 1 | Reference Device 2 | Remark |
|---|---|---|---|---|---|---|---|
| 510(k) | |||||||
| Number | K242710 | K232575 | K160968 | K232939 | K173813 | K130315 | / |
| Trade name | Hair Removal Device | Hair Removal Device | iPulse SmoothSkin | ||||
| Gold | |||||||
| Hair Removal System | IPL Hair Removal Device | IPL Hair Removal Device | |||||
| Joy Version | iPulse Hair Removal | ||||||
| System | / | ||||||
| Model (s) | R3C16-P, R3C16-W, R3C16- | ||||||
| G, R3C16-P Pro, R3C16-W | |||||||
| Pro, R3C16-G Pro | |||||||
| R3505-W, R3505-B, R3505-W | |||||||
| Pro, R3505-B Pro | R2815-G Pro, R2815-G | / | BR223, BR225 | CB-027 | / | / | |
| Indication for | |||||||
| use/ | |||||||
| Intended | |||||||
| use | Hair Removal Device is an | ||||||
| over-the-counter device | |||||||
| intended for removal of | |||||||
| unwanted body hair and/or | |||||||
| facial hair. | Hair Removal Device is an | ||||||
| over-the-counter device | |||||||
| intended for removal of | |||||||
| unwanted body hair and/or | |||||||
| facial hair. | The iPulse SmoothSkin | ||||||
| Gold Hair Removal System | |||||||
| is indicated for the removal | |||||||
| of unwanted hair. The iPulse | |||||||
| Smoothskin Gold is also | |||||||
| indicated for the permanent | |||||||
| reduction in hair regrowth, | |||||||
| defined as the long-term, | |||||||
| stable reduction in the | |||||||
| number of hairs regrowing | |||||||
| when measured at 6, 9 and | |||||||
| 12 months after the | |||||||
| completion of a treatment | |||||||
| regime. | The IPL Hair Removal | ||||||
| Device is indicated for the | |||||||
| removal for unwanted | |||||||
| hair. The IPL Hair | |||||||
| Removal Device is also | |||||||
| indicated for the | |||||||
| permanent reduction in | |||||||
| hair regrowth, defined as | |||||||
| the long-term, stable | |||||||
| reduction in the number of | |||||||
| hairs regrowing when | |||||||
| measured at 6, 9 and 12 | |||||||
| months after the | |||||||
| completion of the | |||||||
| treatment regime. | The IPL Hair Removal | ||||||
| Device Joy Version is | |||||||
| indicated for the removal | |||||||
| of unwanted hair. The | |||||||
| device is also indicated for | |||||||
| the permanent reduction in | |||||||
| hair regrowth, defined as | |||||||
| the long-term, stable | |||||||
| reduction in the number of | |||||||
| hairs regrowing when | |||||||
| measured at 6, 9 and 12 | |||||||
| months after the | |||||||
| completion of a treatment | |||||||
| regime. The device is used | |||||||
| for adults with Fitzpatrick | |||||||
| skin types I - IV. | The iPulse Hair | ||||||
| Removal System is | |||||||
| an Over-the-counter | |||||||
| device intended for | |||||||
| the removal of | |||||||
| unwanted hair. | Same | ||||||
| Prescription or | |||||||
| OTC | OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Device design | |||||||
| Source energy | An external power supply | An external power supply | External Power supply | External Power supply | Supplied by external | ||
| adapter | Supplied by external | ||||||
| power converter | Same | ||||||
| Power supply | 100~240V, 50/60Hz | 100~240V, 50/60Hz | 110V or 230V, 50/60Hz | Not public | 100~240V,50/60Hz | Not public | Same |
| Dimension | |||||||
| (mm) | R3C16 series: 1857040mm | ||||||
| R3505 series: 19811751mm | 19411745mm | Not public | Not public | 12678200mm | Not public | Different | |
| Sterilization | Not required | Not required | Not required | Not required | Not required | Not public | Same |
| Output specification | |||||||
| Comparison | |||||||
| Elements | Subject Device | Predicate Device 1 | Predicate Device 2 | Predicate device 3 | Reference Device 1 | Reference Device 2 | Remark |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy | |||||||
| medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon | |
| Arc | |||||||
| Flashlamp | Same | ||||||
| Wavelength | |||||||
| range | 530~1200nm | 530-1200nm | 510-1100nm | 510〜1100nm | 510-1200nm | 530-1100nm | Same |
| Energy density | R3C16-P, R3C16-W, R3C16- | ||||||
| G: 1.56J/cm²~4.69J/cm² ; | |||||||
| R3C16-P Pro, R3C16-W Pro, | |||||||
| R3C16-G | |||||||
| Pro: | |||||||
| 1.39J/cm²~4.17J/cm² | |||||||
| R3505-W, | |||||||
| R3505-B: | |||||||
| 3.57J/cm²~7.5J/cm²; | |||||||
| R3505-W Pro, R3505-B Pro: | |||||||
| 3.03J/cm²~6.36J/cm² | Max. 5.2J/cm² | ||||||
| (range | |||||||
| in | |||||||
| 1.2J/cm²~5.2J/cm²) | 3-6J/cm² | Max.6.0J/cm² | 1.8~5.1J/cm² | 7-10J/cm² | Similar | ||
| Spot size | R3C16-P, R3C16-W, R3C16- | ||||||
| G: 3.2±0.25cm² | |||||||
| R3C16-P Pro, R3C16-W Pro, | |||||||
| R3C16-G Pro: 3.6±0.25cm² | |||||||
| R3505-W, | |||||||
| R3505-B: | |||||||
| 2.8±0.25cm²; | |||||||
| R3505-W Pro, R3505-B Pro: | |||||||
| 3.3±0.25cm² | 3.4±0.25 cm² | 3cm² (3cm by 1cm) | 3.36cm² | Body: 4.2cm² | |||
| Bikini and face: 2.0cm² | 3cm² (1.3cm by 2.4 | ||||||
| cm) | Similar | ||||||
| Pulse duration | R3C16 series: 6-11ms | ||||||
| R3505 series: 11~12ms | 8.5±2.5ms | ||||||
| (range in 6ms~11ms) | 2ms to 10ms | 8~12ms | 9.2~11.2ms | Variable - | |||
| Single pulse: 25ms | |||||||
| Double Pulse: 20ms | |||||||
| on, 60ms off. | Similar | ||||||
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Delivery | |||||||
| device | Direct illumination to tissue | Direct | |||||
| illumination | |||||||
| to | |||||||
| tissue | Direct illumination to tissue | Direct | |||||
| illumination | |||||||
| to | |||||||
| tissue | Direct | ||||||
| illumination | |||||||
| to | |||||||
| tissue | Direct Illumination | ||||||
| To Tissue | Same | ||||||
| Output | |||||||
| intensity level | 9 levels | 9 levels | Not public | Not public | 5 levels | Not public | Same |
| Software/ | |||||||
| Firmware/ | |||||||
| Microprocesso | |||||||
| r Control? | Yes | Yes | Yes | Yes | Yes | Not public | Same |
8
9
VII. Non-Clinical Testing
The following performance data were provided in support of the substantial equivalence determination.
-
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
-
IEC 60601-1: 2020, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2: 2020, Medical electrical equipments for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11: 2020. 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: 2022, Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
-
IEC 62471: 2006, Photobiological safety of lamps and lamp systems
IEC 60601-1-6: 2020, Medical electrical equipments for basic safety and essential performance -Collateral standard: Usability
VIII. Clinical Testing
Not applicable.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as efforms as well as the legally marketed predicate devices.