(57 days)
No
The summary describes a standard IPL device based on selective photothermolysis and does not mention any AI or ML components in its operation or software.
No.
A therapeutic device is typically intended to treat a disease, disorder, or injury. This device is for cosmetic hair removal and does not claim to treat any medical condition.
No
The device is intended for hair removal, a cosmetic function, not for diagnosing any medical condition.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL)" device that uses light at specific wavelengths and is powered by an external adapter with a finger switch for activation. This indicates it is a hardware device that emits light, not a software-only device. While it mentions software verification and validation, this is for the software controlling the hardware, not the device itself being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "removal of unwanted body and/or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description details how the device works using Intense Pulsed Light (IPL) to reduce hair growth. This is a physical treatment applied to the body, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a person's health status, disease, or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. This IPL hair removal device does not fit that description.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed 15 models with the same IPL technology for hair removal, which is model LS-T121/12/A/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12 T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140. The device works below the skin' s surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 510-1200m and 600-1200mm. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter, home-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 subject 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", as recognized by FDA. The following testing was performed to, and passed, including:
- 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
Electrical Safety and EMC:
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipments 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: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirent for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- IEC 60601-2-83:2019 Medical electrical equipments for the basic safety and essential performance of home light therapy equipment
Eye Safety:
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
Software Verification and Validation:
Software documentation consistent with basic documentation 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 device and reference device.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 9, 2024
Shenzhen Lescolton Electrical Appliance Co., Ltd % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China
Re: K241343
Trade/Device Name: IPL Hair Removal Device (LS-T121A, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138. LS-T139. LS-T140) 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: May 11, 2024 Received: May 13, 2024
Dear Youshan Gong:
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
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.
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 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.
Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.07.09 09:34:36
-04'00'
for Tanisha Hithe
2
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) K241343
Device Name
IPL Hair Removal Device Model(s): LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LS-T130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140
Indications for Use (Describe)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body 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
K241343 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2024-6-17
I. Submitter
Shenzhen Lescolton Electrical Appliance Co., Ltd
Room 301, Building 04, No. A3, Fourth Industrial Zone, Heshuikou Community, Matian Street, Guangdong, China
Post code: 518100 Tel.: 400 153 8008
Qixiang Liu Management representative Tel: +86-13530009850 E-mail: info(@lescolton.com
II. Device
Name of Device: IPL Hair Removal Device Model(s); LS-T121, LS-T121B, LS-T121C, LS-T130, LS-T130A, LS-T130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140 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 and Reference Device
5
ଚ୍ଚ Predicate Device
■ For LS-T133/135/136/137, LS-T134/138/139/140
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| Shen Zhen CosBeauty | ||
| Co., Ltd. | IPL Hair Removal Device Joy | |
| Version | K173813 |
■ For LS-T121/121A/121B/121C, LS-T130/130A/130B
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| Shenzhen Lescolton | ||
| Electrical Appliance | ||
| Co., Ltd | IPL Hair Removal Device | K232499 |
> Reference Device
■ For LS-T133/135/136/137, LS-T134/138/139/140
| Manufacturer | Reference Device | 510(k) Number |
|---|---|---|
| Shenzhen Jizhimei | ||
| Technology Co., Ltd. | IPL Cooling Hair Removal | |
| Device | K230360 |
■ For LS-T121/121A/121B/121C, LS-T130/130A/130B
| Manufacturer | Reference Device | 510(k) Number |
|---|---|---|
| Shenzhen IONKA | Hand-held IPL device (IPL | K230739 |
| Medical Technology | Home Use Hair Removal |
6
| Manufacturer | Reference Device | 510(k) Number |
|---|---|---|
| Co., Ltd. | Device |
IV. Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed 15 models with the same IPL technology for hair removal, which is model LS-T121/12/A/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12/12 T130/130A/130B, LS-T133/135/136/137, LS-T134/138/139/140. The device works below the skin' s surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch.
IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 510-1200m and 600-1200mm. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
V. Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
VI. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| LS- | ||
| T121/121A/121B/121C, | ||
| LS-T130/130A/130B, LS- | ||
| T133/135/136/137, LS- | ||
| T134/138/139/140 | Host of machine (including air outlet, treatment | |
| window, air inlet, buttons) | PC, ABS, PC+ABS, | |
| ADC12, Al2O3 | ||
| (fineness>99.995%), | ||
| PEEK+30%GF, | ||
| PC2805+POM |
7
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section Biocompatibility Discussion.
VII.Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same intended use as the predicate. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate devices. Any minor differences between the subject device and the listed predicate device and reference devices of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference devices for its intended use.
IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications and performance:
| Compariso
n
| Elements | Subject device | Predicate Device | Reference Device |
|---|---|---|---|
| 510(k) | |||
| Number | K241343 | K173813 | K230360 |
| Trade | |||
| name | IPL Hair Removal Device | IPL Hair Removal Device | |
| Joy Version | IPL Cooling Hair | ||
| Removal Device | |||
| Manufactur | |||
| er | Shenzhen Lescolton Electrical | ||
| Appliance Co., Ltd | Shen Zhen CosBeauty Co., | ||
| Ltd. | Shenzhen Jizhimei | ||
| Technology Co., Ltd. | |||
| Regulation | |||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Product | OHT | OHT | OHT |
| Compariso | |||
| n | |||
| Elements | Subject device | Predicate Device | Reference Device |
| code | |||
| Device | |||
| classificati | |||
| on | Class II | Class II | Class II |
| Indication | |||
| for use/ | |||
| Intended | |||
| use | The IPL Hair Removal Device is | ||
| an over-the-counter device | |||
| intended for removal of | |||
| unwanted body and/ or facial | |||
| hair. | 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 IPL Cooling Hair | ||
| Removal Device is an | |||
| over-the-counter | |||
| device intended for | |||
| removal of unwanted | |||
| body and/or facial | |||
| hair. | |||
| Prescriptio | |||
| n or OTC | OTC | OTC | OTC |
| Wavelengt | |||
| h range | LS-T133/135/136/137: 510- | ||
| 1200nm | |||
| LS-T134/138/139/140: 510- | |||
| 1200nm | 510nm~1200nm Max | 550-1200mm | |
| Compariso | |||
| n | |||
| Elements | Subject device | Predicate Device | Reference Device |
| Energy | |||
| density | LS-T133/135/136/137: 1.8~ | ||
| $5J/cm^2$ | |||
| LS-T134/138/139/140: 1.7~ | |||
| $4.7J/cm^2$ | $5.1 J/cm^2$ | 2~5J/cm² (applicable | |
| for model NBB01) | |||
| 2~4J/cm² (applicable | |||
| for model NBB02) | |||
| Spot size | LS-T133/135/136/137: $5.2 cm^2$ | ||
| LS-T134/138/139/140: $5.6 cm^2$ | Body: 4.2 [cm²], Bikini | ||
| area and Face: 2 [cm²] | $3.6cm^2$ (applicable for | ||
| model NBB01 and | |||
| NBB02) | |||
| Pulse | |||
| duration | LS-T133/135/136/137: 9.20- | ||
| 11.20ms | |||
| LS-T134/138/139/140: 9.20- | |||
| 11.20ms | 9.20~11.20milliseconds | 6.4-7.2ms |
1. For LS-T133/135/136/137, LS-T134/138/139/140
8
9
2. For LS-T121/121A/121B/121C, LS-T130/130A/130B
| Comparison
n
| Elements | Subject device | Predicate Device | Reference Device |
|---|---|---|---|
| 510(k) | |||
| Number | K241343 | K232499 | K230739 |
| Trade | |||
| name | IPL Hair Removal Device | IPL Hair Removal Device | Hand-held IPL device |
| (IPL Home Use Hair | |||
| Removal | |||
| Device) | |||
| Manufactur | Shenzhen Lescolton Electrical | Shenzhen Lescolton | Shenzhen IONKA |
| Compariso | |||
| n | |||
| Elements | Subject device | Predicate Device | Reference Device |
| er | Appliance Co., Ltd | Electrical Appliance Co., | |
| Ltd | Medical Technology | ||
| Co., Ltd. | |||
| Regulation | |||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Product | |||
| code | OHT | OHT | OHT |
| Device | |||
| classificati | |||
| on | Class II | Class II | Class II |
| Indication | |||
| for use/ | |||
| Intended | |||
| use | The IPL Hair Removal Device is | ||
| an over-the-counter device | |||
| intended for removal of | |||
| unwanted body and/ or facial | |||
| hair. | The IPL Hair Removal | ||
| Device is an over-the- | |||
| counter device intended | |||
| for removal of unwanted | |||
| body and/ or facial hair. | IPL Home Use Hair | ||
| Removal Device 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. | |||
| Compariso | |||
| n | |||
| Elements | Subject device | Predicate Device | Reference Device |
| Prescriptio | |||
| n or OTC | OTC | OTC | OTC |
| Wavelengt | |||
| h range | LS-T121: 600-1200nm | ||
| LS-T130: 600-1200nm | LS-T106: 610-1200nm | ||
| LS-T107: 560-1200nm | |||
| LS-T108: 470-1200nm | 510nm〜1200nm | ||
| Energy | |||
| density | LS-T121: 2.5-6.0J/cm2 | ||
| LS-T130: 1.3〜5.7 J/cm2 | LS-T106: 2.0-4.87J/cm2 | ||
| LS-T107: 2.16-5.18J/cm2 | |||
| LS-T108: 2.0-5.62J/cm2 | FZ-608, FZ-608G: | ||
| 3.33 J/cm2 | |||
| FZ-100: 5.43 J/cm2 | |||
| FZ-200: 4.5 J/cm2 | |||
| Spot size | LS-T121: 3.2 cm2 | ||
| LS-T130: 3.6 cm2 | LS-T106: 3.2 cm² | ||
| LS-T107: 3.7 cm² | |||
| LS-T108: 3.2 cm² | 3.0cm² | ||
| Pulse | |||
| duration | LS-T121: 9-12ms | ||
| LS-T130: 0.5-5ms | LS-T106: 0.64-2.4ms | ||
| LS-T107: 7.2-10.8ms | |||
| LS-T108: 6.8-10.2ms | 0.5~0.8 ms |
10
11
VIII. 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 subject 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", as recognized by FDA. The following testing was performed to, and passed, including:
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
12
-
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, the following standards:
-
IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2:2014+A1:2020 Medical electrical equipments 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: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirent for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
-
IEC 60601-2-83:2019 Medical electrical equipments for the basic safety and essential performance of home light therapy equipment
3) Eye Safety
-
IEC 62471:2006 Photobiological safety of lamps and lamp
systems 4) Software Verification and Validation
Software documentation consistent with basic documentation 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.
IX. 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 device and reference device.