(88 days)
Not Found
No
The summary describes a standard IPL hair removal device using a Xenon Arc flashlamp and does not mention any AI or ML components or functionalities.
No
The device is intended for hair removal, which is a cosmetic purpose, not a medical or therapeutic treatment for a disease or condition.
No
The device is intended for hair removal, which is a cosmetic procedure, not for diagnosing a medical condition.
No
The device description explicitly states it consists of a "IPL main body and power adapter two parts" and a "treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp," indicating it is a hardware device that uses software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted body hair and/or facial hair." This is a cosmetic or aesthetic procedure performed directly on the body, not a diagnostic test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device uses Intense Pulsed Light (IPL) technology to target hair follicles. This is a physical interaction with the body, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, sample collection, analysis of biological markers, or diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This IPL hair removal device does not fit that description.
N/A
Intended Use / Indications for Use
IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Product codes
OHT
Device Description
The IPL Hair removal is a personal, light-based, hair reduction device intended to be sold overthe-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The device consists of IPL main body and power adapter two parts, and treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is power from power adapter via an external power.
The IPL Hair removal includes V501, V201, V301-s, and V401 four models. Their intended use, performance, circuit principle, structure design and operation are basically identical, with the differences contains the appearance of the product , the size of PCB board and LCD display contents; and these differences do not affect or change the intended use of the device.
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 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)
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 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 Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 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 Medical electrical equipment -- 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
- IEC 62471 Photobiological safety of lamps and lamp systems
- Software Verification and Validation
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.
Summary: Based on the above performance as documented in this application, IPL Hair removal was found to have a safety and effectiveness profile that is similar 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 26, 2021
Shenzhen Weikai Technology CO.,LTD % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road, Nanshan District Shenzhen, Guangdong 518000 China
Re: K203510
Trade/Device Name: IPL Hair removal 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: November 11, 2020 Received: November 30, 2020
Dear Rain Yip:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Purva U. Pandya -S
Purva Pandya 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) K203510
Device Name IPL Hair removal V501, V201, V301-s, V401
Indications for Use (Describe)
IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2020-11-11
I. Submitter
Shenzhen Weikai Technology CO.,LTD Rm.101&201, Bldg.4, Haoer Jiashitai Technology Park, Fengtang Avenue No.164, Heping Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518118 Tel.: +86 0755 8337 4619
LI JING General Manager Tel: +86 180 1876 9288 Email: 50917560@qq.com
II. Device
Name of Device: IPL Hair removal Model(s): V501, V201, V301-s, V401 Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification 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
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen | |||
| Technology Co.,Ltd. | Bosidin IPL Home Use Hair Removal | ||
| Device/D-1128 | K192432 | Nov.8, 2019 | |
| Shen Zhen CosBeauty Co., | |||
| Ltd | PerfectSmooth/CB-014 | K161428 | Mar. 23, 2017 |
| CyDen Limited. | iPulse SmoothSkin Gold | ||
| Hair Removal System | K160968 | Apr.14, 2016 |
IV. Device Description
The IPL Hair removal is a personal, light-based, hair reduction device intended to be sold overthe-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The device consists of IPL main body and power adapter two parts, and
4
treatment window located in the main body which is the source of optical radiation, namely a Xenon Arc flashlamp; and the device is power from power adapter via an external power.
The IPL Hair removal includes V501, V201, V301-s, and V401 four models. Their intended use, performance, circuit principle, structure design and operation are basically identical, with the differences contains the appearance of the product , the size of PCB board and LCD display contents; and these differences do not affect or change the intended use of the device.
V. Indications for Use
IPL Hair removal is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
VI. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair removal has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the IPL Hair removal may be found substantially equivalent to its predicate device.
IPL Hair removal is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
-
K192432, "IPL Home Use Hair Removal Device/D-1128", manufactured by "Shenzhen Bosidin Technology Co.,Ltd. " in Guangdong, China
-
K161428, "PerfectSmooth", manufactured by "Shen Zhen CosBeauty Co., Ltd" in Guangdong, China
| Comparison | Subject Device | Predicate Device | ||
|---|---|---|---|---|
| Elements | K192432 | |||
| (Primary) | K161428 | K160968 | ||
| K Number | Pending | K192432 | K161428 | K160968 |
| Trade name | IPL Hair removal | IPL Home Use | ||
| Hair Removal | ||||
| Device | PerfectSmooth | iPulse | ||
| SmoothSkin | ||||
| Gold Hair | ||||
| Removal System | ||||
| Wavelength | ||||
| range | 530-1200nm | Regular window: | ||
| 510-1100nm | ||||
| Filter window: | ||||
| 600-1100nm | ≥510nm | 510-1100nm | ||
| Energy | ||||
| medium | Xenon | |||
| Arc | ||||
| Flashlamp | Xenon | |||
| Arc | ||||
| Flashlamp | Xenon | |||
| Arc | ||||
| Flashlamp | Xenon | |||
| Arc | ||||
| Flashlamp | ||||
| Energy density | 3.0~4.0J/cm2 | 2.0~4.0J/cm2 | 4.7 J/cm2Max. | 3~6 J/cm2 |
| Spot size | 3.7cm2 | Regular window: | 4.5 cm2 | 3 (3cm by 1cm) |
| Comparison | ||||
| Elements | Subject Device | Predicate Device | ||
| K192432 | ||||
| (Primary) | K161428 | K160968 | ||
| 4.5cm ²; 2.0cm ² | ||||
| Filter window: | ||||
| 2.5cm ² | ||||
| Pulse duration | 4~13ms | 7.5~14ms | 11-13ms | 2-10ms |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch |
| Delivery device | Direct illumination | |||
| to tissue | Direct | |||
| illumination | ||||
| tissue | Direct | |||
| illumination | ||||
| tissue | Direct | |||
| illumination | ||||
| tissue | ||||
| Indication for | ||||
| use/Intended | ||||
| use | IPL Hair removal | |||
| is an over-the- | ||||
| counter device | ||||
| intended for | ||||
| removal of | ||||
| unwanted body | ||||
| hair and/or facial | ||||
| hair. | IPL Home Use | |||
| Hair Removal | ||||
| Device is an | ||||
| over-the-counter | ||||
| device intended | ||||
| for removal of | ||||
| unwanted body | ||||
| and/or facial hair. | 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 | OTC | OTC |
- K160968, "iPulse SmoothSkin Gold Hair Removal System", manufactured by "CyDen Limited" in Wales, UK
5
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
6
The biocompatibility evaluation for the body-contacting components of the IPL Hair removal 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 Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 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 Medical electrical equipment -- Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
3) Eye Safety
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
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.
Summary
Based on the above performance as documented in this application, IPL Hair removal was found to have a safety and effectiveness profile that is similar to the predicate devices.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the IPL Hair removal is to be concluded substantial equivalent to its predicate devices.