(304 days)
No
The summary describes a standard IPL hair removal device with no mention of AI or ML capabilities, image processing, or data training/testing.
No
The device is described as a hair reduction device for cosmetic/aesthetic use, not for treating a disease or disorder.
No
The device is intended for hair removal, which is a cosmetic purpose, not a diagnostic one. Its function is to reduce hair, not to diagnose a condition or disease.
No
The device description explicitly states it consists of an "IPL base unit and AC adapter, and a detachable lamp cap located in the IPL base unit which is the source of optical radiation, namely a Xenon flashlamp." This indicates the device is a hardware-based system utilizing IPL technology, not a software-only device. While software is mentioned in the performance studies, it is part of the overall hardware system.
Based on the provided information, the PerfectSmooth device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of unwanted hair. This is a cosmetic/aesthetic purpose, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device uses IPL technology to target hair follicles. This is a physical interaction with the body's surface, not an analysis of biological samples.
- Anatomical Site: The device is applied to the skin (underarms, face, legs). IVD devices typically interact with internal biological samples.
- Performance Studies: The performance studies focus on safety (biocompatibility, electrical safety, eye safety), software validation, and usability. These are relevant for a consumer-use device, but not the types of studies (like analytical and clinical performance) required for IVD devices.
In summary, the PerfectSmooth is a light-based device for hair reduction, which falls under the category of cosmetic or aesthetic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Product codes
OHT
Device Description
The PerfectSmooth is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. And it consists of IPL base unit and AC adapter, and a detachable lamp cap located in the IPL base unit which is the source of optical radiation, namely a Xenon flashlamp. The device is power from AC adapter via an external power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
But not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
Nonclinical, performance and usability testing has been completed on the PerfectSmooth.
Nonclinical testing included biocompatibility, electrical safety and software testing.
Biocompatibility test: The body-contacting components of the device (mainly is plastic enclosure) were tested according to ISO 10993-1 for skin-contacting biocompatibility:
- A ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- A ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Electrical safety:
- A IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Eye safety:
- A IEC 62471 Photobiological safety of lamps and lamp systems
Software verification and validation:
- A Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Usability study:
- Usability testing (OTC Study) was completed in 20 subjects to evaluate device human factors A and label comprehension.
In addition to the above, the Performance testing also included appearance, function, package and reliability testing of the finished product, to in order to the integrity and quality of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2017
Shen Zhen CosBeauty Co., Ltd. % Yuchen Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Room 3005, Area B, Bldg.1, Southward Ruifeng Business Center, Guimiao Road Shenzhen, 518000 CN Guangdong
Re: K161428
Trade/Device Name: PerfectSmooth 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: January 5, 2017 Received: January 9, 2017
Dear Mr. Che:
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 (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. 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.
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
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161428
Device Name PerfectSmooth (Model: CB-014)
Indications for Use (Describe)
The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
| 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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510(k) Summary
"510(k) Summary" as required by section 807.92(c).
(1) Applicant information:
| Applicant: | Shen Zhen CosBeauty Co., Ltd |
|---|---|
| UnitA-3F, Qiao De Industrial Park, Tian Liao, Guang Ming District | |
| Shenzhen, China | |
| Contact person: | Nicole Hu |
| Phone number: | +86 1831 685 8036 |
| Fax number: | +86 755 8629 0505 |
| Email: | lizan@cos-beauty.com |
| Application date: | 2016.05.04 |
| Application reason | New device, for the first time to apply. |
(2) Device name:
| Trade name/Model: | PerfectSmooth/CB-014 |
|---|---|
| Common 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: | Class II |
| Regulation number: | 21 CFR 878.4810 |
| Product code | OHT |
| Review panel: | General & Plastic Surgery |
(3) Predicate device:
iPulse SmoothSkin Gold Hair Removal System, cleared Apr. 14, 2016 (K160968)
(4) Description of device:
The PerfectSmooth is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. And it consists of IPL base unit and AC adapter, and a detachable lamp cap located in the IPL base unit which is the source of optical radiation, namely a Xenon flashlamp. The device is power from AC adapter via an external power.
(5) Intended use / indications:
The PerfectSmooth is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.
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(6) Performance data:
Nonclinical, performance and usability testing has been completed on the PerfectSmooth.
Nonclinical testing included biocompatibility, electrical safety and software testing.
Biocompatibility test: The body-contacting components of the device (mainly is plastic enclosure) were tested according to ISO 10993-1 for skin-contacting biocompatibility:
- A ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- A ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Electrical safety:
- A IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Eye safety:
- A IEC 62471 Photobiological safety of lamps and lamp systems
Software verification and validation:
- A Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Usability study:
- Usability testing (OTC Study) was completed in 20 subjects to evaluate device human factors A and label comprehension.
In addition to the above, the Performance testing also included appearance, function, package and reliability testing of the finished product, to in order to the integrity and quality of the device.
(7) Comparison to predicate device
The PerfectSmooth has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the targeted device and the listed predicate device do not raise any issues of safety or efficacy. Performance data supports that the device is as safe and as effective as the predicate device for its intended use. Therefore, the PerfectSmooth may be found substantially equivalent to its predicate device.
Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the provided
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below.
| / | Targeted device | Predicate device |
|---|---|---|
| Common name | Light Based Over-The-Counter | |
| Hair Removal | Light Based Over-The-Counter | |
| Hair Removal | ||
| Trade name | PerfectSmooth | iPulse SmoothSkin Gold Hair |
| Removal System | ||
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Pulse duration | 11-13milliseconds | 2-10milliseconds |
| Energy density | $4.7 J/cm^2$ | $3-6J/cm^2$ |
| Spot size | 4.5 | 3 (3cm by 1cm) |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue |
| Pulsing control | Finger switch | Finger switch |
| Skin tone sensor | Optical measurement removable | |
| from base unit | ||
| Sensor fixed in base unit and can be | ||
| moved to treatment part | Optical Measurement | |
| Integral to device. | ||
| Continuous measurement. | ||
| Indications for | ||
| use/Intended use | The PerfectSmooth is an | |
| over-the-counter device intended | ||
| for removal of unwanted hair such | ||
| as but not limited to small areas | ||
| such as underarm and facial hair | ||
| below the chin line and large areas | ||
| such as legs. | 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. | ||
| Location for use | OTC | OTC |
(8) Conclusion:
Based on the comparison and analysis, the PerfectSmooth is determined to be Substantially Equivalent (SE) to the predicate device.