(132 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on basic functionalities like IPL emission, skin contact sensing, and cooling. The performance studies are standard for electrical and light safety, biocompatibility, and basic software validation, not indicative of complex AI/ML algorithms.
No.
The device is indicated for hair removal and permanent hair regrowth reduction. While it alters a bodily function (hair growth), the primary indication of hair removal is usually considered cosmetic and not for treating or diagnosing a disease or injury, which is the defining characteristic of a therapeutic device. It is more commonly regulated as a cosmetic device or for cosmetic indications.
No
The device is an IPL hair removal device, indicated for the removal and permanent reduction of unwanted hair. Its function is to treat hair, not to diagnose any condition.
No
The device description clearly outlines a physical device that emits Intense Pulsed Light (IPL) and includes hardware components such as a sapphire treatment window, external power adapter, finger switch, and skin sensor. While software is mentioned for verification and validation, the core functionality and components are hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The Ice Cooling IPL Hair Removal Device works by applying Intense Pulsed Light directly to the skin to target hair follicles. It is a physical treatment applied to the body, not a test performed on a sample from the body.
- Intended Use: The intended use is for the removal and permanent reduction of unwanted hair. This is a cosmetic or aesthetic procedure, not a diagnostic test.
- Device Description: The description details how the device emits light pulses and interacts with the skin, not how it analyzes biological samples.
The information provided clearly indicates that this device is a therapeutic or aesthetic device used for hair removal, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and single-person-use device for hair reduction by using 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.
This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
lips, underarms, bikini lines, arms, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter, home-use and single-person-use 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)
-
Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal 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", as recognized by FDA. The following testing was performed to, and passed, including:
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
ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity -
Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:
IEC 60601- 1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-57:2011 Medical electrical equipment-Part 2-57: Particular requirements basic safety and essential performance of non-laser source equipment intended for for the therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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 -
Light Safety:
IEC 62471:2006 Photobiological safety of lamps and lamp systems -
Software Verification and Validation: Software documentation consistent with Basic Documentation Level was submitted in this 510(k). System 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.
-
Usability: The product usability has been evaluated and validated according to the following standard and FDA guidance.
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Conclusion: The proposed device uses technology that is similar to the predicate device. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use, and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the 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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 9, 2024
Shenzhen Ulike Smart Electronics Co., Ltd. Yang Blue Registration Director 810, Bldg 1,Xunmei Science and Technology Plaza,No. 8 Keyuan Rd., Science Park Community, Yuehai Sub-District, Nanshan Dis Shenzhen, China
Re: K241205
Trade/Device Name: Y6S GR, Y6S GA, Y6S GT, Y6S JU, Y6S MU, Y6S OG, Y6S CH, Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE 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: April 30, 2024 Received: April 30, 2024
Dear Yang Blue:
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 (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 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). 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,
TANISHA TANISHA L.HITHE -S L. HITHE - C Date: 2024.09.09
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) K241205
Device Name
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA, Y6S GT, Y6S JU, Y6S JM, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
Indications for Use (Describe)
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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.
| Type of Use (Select one or both, as applicable): | Production Use (Part 21 CFR 601 Subpart D) Own-Tissue Standard (21 CFR 601 Subpart C) |
|---|---|
| -------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Shenzhen Ulike Smart Electronics Co., Ltd.
510(k) Summary of K241205
I. Submitter
Shenzhen Ulike Smart Electronics Co.,Ltd. Address:810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P.R. China Contact person: Blue Yang Email: blue@ulike.com The date the summary was prepared: 09/08/2024
II. Device
Name of Device: Ice Cooling IPL Hair Removal Device Model(s): Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE 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. Device Description
Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and single-person-use device for hair reduction by using 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.
This product emits light pulses and is designed to be suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes a cooling function to cool the skin during the hair removal process to provide users with a more comfortable experience.
5
Shenzhen Ulike Smart Electronics Co., Ltd.
IV.Indications for Use
Ice Cooling IPL Hair Removal Device with sapphire treatment window 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.
V. Comparison of Technological Characteristics With the Predicate
Devices
The Ice Cooling IPL Hair Removal Device has the same intended use and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise new types of questions regarding safety and efficacy when the device is used for the indications for use stated above. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, specifications and performance:
| Comparison Items | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| 510(k) number | K241205 | K221002 | K240264 |
| Trade Name | Ice Cooling IPL Hair | ||
| Removal Device | IPL Hair Removal | ||
| Device | Home use hair | ||
| removal device | |||
| Manufacturer | Shenzhen Ulike Smart | ||
| Electronics Co., Ltd. | Shenzhen Ulike | ||
| Smart Electronics | |||
| Co., Ltd. | Shenzhen Mlay | ||
| Intelligent | |||
| Technology Co., | |||
| Ltd. | |||
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR |
| 878.4810 | |||
| Product code | OHT | OHT | OHT |
| Device | |||
| classification | Class II | Class II | Class II |
| Indication for use/ | |||
| Intended use | Ice Cooling IPL Hair | ||
| Removal Device with | |||
| sapphire treatment | |||
| window is indicated | |||
| for the removal of | |||
| unwanted hair. The | |||
| device is also | |||
| indicated for the | |||
| permanent reduction | IPL Hair Removal | ||
| Device is indicated | |||
| for the removal of | |||
| unwanted hair. The | |||
| device is also | |||
| indicated for the | |||
| permanent | |||
| reduction in hair | |||
| regrowth defined | The Home use | ||
| hair removal | |||
| device is an | |||
| over-the-counter | |||
| device intended | |||
| for removal of | |||
| unwanted hair | |||
| such as but not | |||
| limited to small | |||
| in hair regrowth, | as the long-term, | ||
| stable reduction in | areas such as | ||
| defined as the | the number of hairs | underarm and | |
| long-term, stable | regrowing when | facial hair below | |
| reduction in the | measured at 6, 9 | the chin line and | |
| number of hairs | and 12 months after | large areas such | |
| regrowing when | the completion of a | as legs, in | |
| measured at 6, 9 and | treatment regime. | patients with | |
| 12 months after the | Fitzpatrick Skin | ||
| completion of a | Phototypes I-V. | ||
| treatment regime. | |||
| Prescription or | OTC | OTC | OTC |
| OTC | |||
| Applicable skin | Fitzpatrick Skin Types | Fitzpatrick Skin Types | Fitzpatrick Skin Types |
| I-V | I-V | I-V | |
| Treatment area | Large areas (e.g. arms, | ||
| legs, chest) and small | Large areas (e.g. | ||
| arms, legs, chest) | |||
| and small areas | small areas such | ||
| as underarm and | |||
| facial hair below | |||
| the chin line and | |||
| large areas such | |||
| as legs | |||
| areas (e.g. moustache) | (e.g. moustache) | ||
| Source energy | Supplied by external | ||
| adapter | Supplied by | ||
| external | |||
| adapter | Not known | ||
| Power supply | 100-240V~, 50/60Hz | 100-240V~, | |
| 50/60Hz | Not known | ||
| Dimension | 114×89×45mm | 60.5(W)x38(H)x16 | |
| 9.7(L)mm | Not known | ||
| Sterilization | Not required | Not required | Not required |
| Light source | Intense Pulsed Light | Intense Pulsed | |
| Light | Intense Pulsed | ||
| Light | |||
| Energy medium | Xenon Arc Flashlamp | Xenon Arc | |
| Flashlamp | Xenon Arc | ||
| Flashlamp | |||
| Wavelength range | 550-1200nm | 550-1200nm | 510~1200nm |
| Energy density | $1.45J/cm^2$ ~ $5J/cm^2$ | $3.03-5.3J/cm^2$ | $1.37~5.23J/cm^2$ |
| Output energy | 4.35J~15J | 10.0~17.5J | Not known |
| Spot size | $3.0cm^2$ | $3.3cm^2$ | $3.5cm^2$ , $3.9cm^2$ |
| Pulse width | 0.88~6.6ms | 7-10ms | 0.5~8.0ms |
| Pulsing control | Finger switch | Finger switch | Finger switch |
| Delivery device | Direct illumination to | ||
| tissue | Direct illumination | ||
| to | |||
| tissue | Direct | ||
| illumination to | |||
| tissue | |||
| Output intensity | |||
| level | 3 Levels | 5 Levels | Not known |
| Software/Firmware/ | Yes | Yes | Yes |
6
7
| Microprocess or
| Control? | |||
|---|---|---|---|
| Electrical safety | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| IEC 60601-2-57 | |||
| IEC 60601-2-83 | ANSI AAMI ES | ||
| 60601-1 | |||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| IEC 60601-2-57 | |||
| IEC 60601-2-83 | ANSI AAMI ES | ||
| 60601-1 | |||
| IEC 60601-1-2 | |||
| IEC 60601-1-11 | |||
| IEC 60601-2-57 | |||
| IEC 60601-2-83 | |||
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 |
| Biocompatibility | ISO 10993-5 | ||
| ISO 10993-10 | |||
| ISO 10993-23 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-5 | ||
| ISO 10993-10 |
Note 1:
Although there is a minor difference of the energy density range between the subject device and predicate devices, the maximum energy density of subject device is within the range of the value of the predicate devices and the difference is not considered to raise concerns regarding safety or effectiveness .
Note 2:
There are minor differences in spot sizes between the subject device and the predicate devices. Given that the maximum energy density and pulse width range of the subject device is within the range of the applicable predicate, the differences in spot sizes are not considered to raise concerns regarding safety and effectiveness.
Note 3:
Although there are difference in the pulse duration range between the subject device and predicate devices, the maximum and minimum pulse duration of subject device is within the range of the value of the applicable predicate device. Given the subject device's energy density, treatment window size, and other parameters, the difference in pulse duration range is not considered to raise concerns regarding safety and effectiveness.
Summary of performance testing
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 IPL Hair Removal 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", as recognized by FDA. The following testing was performed to, and passed, including:
ISO 10993-10:2021、Biological evaluation of medical devices Part 10: Tests for skin sensitization
8
Shenzhen Ulike Smart Electronics Co., Ltd.
ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
IEC 60601- 1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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 for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
IEC 60601-2-57:2011 Medical electrical equipment-Part 2-57: Particular requirements basic safety and essential performance of non-laser source equipment intended for for the therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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
- Light Safetv
IEC 62471:2006 Photobiological safety of lamps and lamp systems
- Software Verification and Validation
Software documentation consistent with Basic Documentation Level was submitted in this 510(k). System 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.
- Usability
The product usability has been evaluated and validated according to the following standard and FDA guidance.
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Conclusion: The proposed device uses technology that is similar to the predicate device. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use, and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the predicate devices