(90 days)
No
The description focuses on standard IPL technology and safety features, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as an "IPL Hair Removal Device" intended for "removal of unwanted body hair," which is cosmetic in nature, not therapeutic.
No
The intended use of the device is for hair removal, which is a cosmetic procedure, not for diagnosing any medical condition.
No
The device description explicitly details physical hardware components such as the "IPL main body," "power adapter," "flash window," and "Xenon flashlamp." It also mentions "Electrical Safety and Eye Safety" testing, which is relevant to hardware. While software verification and validation are mentioned, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The IPL Hair Removal Device uses light energy applied directly to the body to reduce hair growth. It does not analyze any biological samples.
- Intended Use: The stated intended use is "removal of unwanted body hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
The device is a therapeutic or aesthetic device that interacts directly with the body, not an IVD that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The IPL Hair Removal Device 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 Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse. There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A is designed to 3.0cm², model S1, S2, S3, and S4 is designed to 4.1cm², as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Healthcare Environment / 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 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 battery of testing was performed to, and passed, including: ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity, ISO 10993-10 Biological Evaluation of Medical Devices –Par t 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 -- 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, 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.
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 shows 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2022
Shenzhen Yuwei Electronic 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: K220222
Trade/Device Name: IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 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 18, 2022 Received: January 26, 2022
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/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.
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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 Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220222
Device Name
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
Indications for Use (Describe)
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body 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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510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2022-01-18
I. Submitter
Shenzhen Yuwei Electronic Technology Co., Ltd. 409, Building 3, 1970 Science Park, Minzhi Community, Minzhi Street, Longhua District, Shenzhen, P.R.C 518000 Tel.: +86 186 7634 5905
Liu Xuemeng Quality Manager Tel: +86 186 7634 5905 Email: a369235@126.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): S1-A, S2-A, S1, S2, S3, S4 Common or Usual Name: Light Based Over-The-Counter For 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
Predicate device: Home Use IPL Beauty Device/MS-208B, K210311, cleared by July 23, 2021
Reference device: IPL Home Use Hair Removal Device/D-1128, K192432, cleared by November 8. 2019
IV. Device Description
The IPL Hair Removal Device 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 Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body and power adapter two parts and it is only powered by the external power adapter, as well as the flash window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and its IPL emission activation is by finger switch. If the flash window of the device is not properly applied to the treatment area, the device cannot be triggered a pulse.
4
There are six models in this application: S1-A, S2-A, S1, S2, S3, and S4. According to the declaration of the manufacturer, the difference of all models is mainly the exception of the product appearance, display contents on the display and the spot size of treatment window which does not affect the intended use. The spot size of model S1-A is designed to 3.0cm², model S1, S2, S3, and S4 is designed to 4.1cm², as well as the energy density of the all models is in the range of 2.2~5.6J/cm2.
V. Indications for Use
IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
VI. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device 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 Device may be found substantially equivalent to its predicate device. IPL Hair Removal Device is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance:
| Comparison Elements | Subject Device | Predicate Device K210311 |
|---|---|---|
| K Number | Pending | K210311 |
| Trade name | IPL Hair Removal Device | Home Use IPL Beauty Device |
| Model: MS-208B | ||
| Wavelength range | 610-1100nm | 510-1100nm |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Energy density | $2.2{\sim}5.6 J/cm^2$ | $2.0{\sim}5.1J/cm^2$ |
| Spot size | $3.0cm^2, 4.1cm^2$ | $3.6cm^2$ |
| Pulse duration | 8~14ms | 9-12ms |
| Pulsing control | Finger switch | Finger switch |
| Delivery device | Direct illumination tissue | Direct illumination tissue |
| Indication | ||
| for | ||
| use/Intended use | IPL Hair Removal Device is an | |
| over-the-counter device intended | ||
| for removal of unwanted body | ||
| hair. | The Home Use IPL Beauty | |
| Device 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. | ||
| Location for use | OTC | OTC |
5
VII.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 battery of testing was performed to, and passed, including: > ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro
- Cytotoxicity
-
ISO 10993-10 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 -- 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
-
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.
Summarv
Based on the above performance as documented in this application, the subject device IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device.
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 subject device IPL Hair Removal Device is to be concluded substantial equivalent to its predicate devices.