(52 days)
No
The description focuses on basic hardware components (Xenon lamp, skin sensor, buttons) and standard safety/performance testing (electrical safety, biocompatibility, software validation for moderate concern). There is no mention of AI, ML, image processing for analysis, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
No.
The device is intended for the removal of unwanted hair, which is a cosmetic purpose and not for treating a disease or medical condition.
No
The device is intended for hair removal, a cosmetic function, and does not mention diagnosing any medical condition.
No
The device description clearly outlines physical hardware components such as a Xenon lamp, skin sensor, power adapter, and buttons, indicating it is a hardware device that likely contains embedded software.
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 and/or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description details a light-based device that works on the skin's surface to reduce hair growth. It does not mention analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD-related terms: There are no mentions of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This IPL hair removal device does not fit that definition.
N/A
Intended Use / Indications for Use
The IPL Hair Removal 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
The IPL Hair Removal is a personal. light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It 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. The device mainly contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. For model SL-B287 and SL-B329, they consist of IPL beauty device main body and power adapter (12V3A) two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglass.
The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device, select light intensity level), Flash button (to start flashing) and loe Cooling button (to select ice cooling mode and switch manual / auto flash mode).
For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglass and replacement lampshade.
The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body and/or facial hair.
large areas (e.g. arms, legs) and small areas (e.g. lip)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over the-counter device intended for removal of unwanted body and/or facial hair.
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 Tests Performed:
- Electrical safety, and electromagnetic compatibility Test: Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment - Part 1: 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 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- IEC 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 disturbances -Requirements and tests.
- IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
- Biocompatibility Test: The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Skin Irritation).
- Software verification and validation: Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
- Usability validation: Usability testing was conducted on the IPL Hair Removal, Model: SL-B287, SL-B329, SL-B301-1, SL-B328, which complies with IEC 62366-1 and IEC 60601-1-6.
Summary of Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Shenzhen Semlamp Intelligent Technology Co., Ltd % Cassie Lee Official Correspondent Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 510530 China
Re: K240969
Trade/Device Name: IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) 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: March 27, 2024 Received: April 9, 2024
Dear Cassie Lee:
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.
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"
1
(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 OS 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 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 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.
for
Yan Fu -
e: 2024.05.31 09:10:04 -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
2
Indications for Use
510(k) Number (if known) K240969
Device Name
IPL Hair Removal (SL-B287, SL-B329, SLB301-1, SL-B328)
Indications for Use (Describe)
The IPL Hair Removal 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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3
510(k) Summary of K240969
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Company Name: Shenzhen Semlamp Intelligent Technology Co., Ltd Address: Room 915, Lankun Building, Minkang Road 213, Zhangkeng Community, Minzhi Avenue, Longhua District, Shenzhen, Guangdong, China Contact Person (including title): Qi Wenjun (CEO) Tel: +86 13428733261 Fax: +86 0755-23490305 Post code: 518131 E-mail: info@semlamp.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
Subject Device Information: 2.
Classification Name: Light Based Over-The-Counter Hair Removal Trade Name: IPL Hair Removal Model Name: SL-B287, SL-B329, SL-B301-1, SL-B328 Review Panel: General & Plastic Surgery Product Code: OHT Requlation Number: 21 CFR 878.4810 Requlatory Class: II
Predicate Device Information 3.
Primary Predicate Device
Sponsor: Shenzhen Lescolton Electrical Appliance Co., Ltd. Trade Name: IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) Classification Name: Light Based Over-The-Counter Hair Removal 510(K) Number: K232499 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Requlation Class: II
Reference Device
Sponsor: Shenzhen Wochuan Electronic Co., Ltd Trade Name: IPL Hair Removal, Model: W-1095, W-1098 Classification Name: Light Based Over-The-Counter Hair Removal 510(K) Number: K232124 Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Device Description
4
The IPL Hair Removal is a personal. light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It 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. The device mainly contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The device is for single-person use only. For model SL-B287 and SL-B329, they consist of IPL beauty device main body and power adapter (12V3A) two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver and sunglass.
The user can control the device effectively by the buttons on the main unit. There are 3 operation buttons: Power button (turning on/off the device, select light intensity level), Flash button (to start flashing) and loe Cooling button (to select ice cooling mode and switch manual / auto flash mode).
For model SL-B301-1 and SL-B328, consisting of an IPL beauty device main body and power adapter (12V2A) two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. In addition, the device is equipped with a manual shaver, sunglass and replacement lampshade.
The user can control the device effectively by the buttons on the main unit. There are 2 operation buttons: Power button (turning on/off the device and selecting the level of gears) and Mode/Flash button.
Intended Use / Indications for Use 5.
The IPL Hair Removal is an over the-counter device intended for removal of unwanted body and/or facial hair.
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Device | Remark |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------|
| Company | Shenzhen Semlamp
Intelligent Technology
Co., Ltd | Shenzhen Lescolton
Electrical Appliance
Co., Ltd. | Shenzhen Wochuan
Electronic Co., Ltd | -- |
| Trade Name | IPL Hair Removal, Model:
SL-B287, SL-B329, SL-
B301-1, SL-B328 | IPL Hair Removal
Device (LS-T106,
LS-T107, LS-T108) | IPL Hair Removal,
Model W-1095, W-
1098 | -- |
| Classification
Name | Light Based Over-The-
Counter Hair Removal | Light Based Over-
The-Counter Hair
Removal | Light Based Over-
The-Counter Hair
Removal | -- |
| 510(k) Number | K240969 | K232499 | K232124 | -- |
| Product Code | OHT | OHT | OHT | Same |
| Class | II | II | II | Sames |
| Intended Use /
Indications for
Use | The IPL Hair Removal 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 Hair Removal is
an over-the-counter
device intended for
removal of unwanted
body and/or facial
hair. | Same |
| Prescription or
OTC | OTC | OTC | OTC | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc | Xenon Arc Flashlamp | Same |
Comparison to predicate devices 6.
Compare with the predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject
5
| Flashlamp | ||||
|---|---|---|---|---|
| Wavelength | ||||
| Range | 470nm-1200nm | LS-T106: 610-1200nm LS-T107: | ||
| 560-1200nm LS- | ||||
| T108: 470-1200nm | 470nm-1100nm | Same | ||
| Pulse duration | 9-12 milliseconds | LS-T106: 0.64-2.4ms | ||
| LS-T107: 7.2-10.8ms | ||||
| LS-T108: 6.8-10.2ms | 4-13ms | Similar | ||
| Note 1 | ||||
| Energy density | SL-B287: 2.2-5.3J/cm² | |||
| SL-B329: 2.2-5.3J/cm² | ||||
| SL-B301-1: 1.9-3.4J/cm² | ||||
| SL-B328: 1.9-3.4J/cm² | LS-T106: 2.0- | |||
| 4.87J/cm² LS-T107: | ||||
| 2.16-5.18J/cm² LS- | ||||
| T108: 2.0-5.62J/cm² | W-1095:1.67~4.46J/cm² | |||
| W-1098:1.16~2.79J/cm² | Similar | |||
| Note 1 | ||||
| Spot size (size of | ||||
| treatment window) | SL-B287: 3.6 cm² | |||
| SL-B329: 3.6 cm² | ||||
| SL-B301-1:4.2 cm²/2 cm² | ||||
| SL-B328: 4.2 cm²/2 cm² | LS-T106: 3.2 cm² | |||
| LS-T107: 3.7 cm² | ||||
| LS-T108: 3.2 cm² | W-1095: 2.69cm² | |||
| W-1098: 4.3cm² | Similar | |||
| Note 2 | ||||
| Delivery device | Direct illumination to | |||
| tissue | Direct illumination to | |||
| tissue | Direct illumination to | |||
| tissue | Same | |||
| Pulsing control | Finger switch | Finger switch | Finger switch | Same |
| Location for use | large areas (e.g. arms, | |||
| legs) and small areas | ||||
| (e.g. lip) | Multiple hair removal | |||
| areas, including | ||||
| small areas (e.g. | ||||
| armpit, bikini lines) | ||||
| and large areas (e.g. | ||||
| arms, legs) | Face, lips, underarms, | |||
| bilini lines, arms, legs, | ||||
| etc | Same | |||
| Safety and EMC | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-57 | ||||
| IEC 62471 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-83 | ||||
| IEC 62471 | IEC 60601-1 | |||
| IEC 60601-1-2 | ||||
| IEC 60601-1-11 | ||||
| IEC 60601-2-83 | ||||
| IEC 62471 | Same | |||
| Biocompatibility | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-5 | |||
| ISO 10993-10 | Same |
Comparison in Detail(s):
Note 1:
Althouqh the "Pulse duration" and "Enerqy density" of the subject device is slightly different from that of the predicate device, the values of the pulse duration and energy density of the subject device are within the range of the reference device. So, this difference will not raise any safety or effectiveness issue.
Note 2:
Although the "Spot size (size of treatment window)" of subject device is a little different from the predicate device, the difference in treatment window size is due to different designs. So, we believe that these differences will not affect the device's performance.
7. Test Summary
- 7.1 Non-Clinical Tests Performed
1) Electrical safety, and electromagnetic compatibility Test
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
6
- � IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment - Part 1: 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 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- � IEC 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 disturbances -Requirements and tests.
- � IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
2) Biocompatibility Test
The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Skin Irritation).
Software verification and validation 3)
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
4) Usability validation
Usability testing was conducted on the IPL Hair Removal, Model: SL-B287, SL-B329, SL-B301-1, SL-B328, which complies with IEC 62366-1 and IEC 60601-1-6.
7.2 Summary of Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
8. Date of the summary prepared: May 7, 2024
9. Final Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated device K232499 and K232124.