(57 days)
Not Found
No
The description focuses on standard IPL technology, a skin sensor for contact detection, and basic electrical/software safety testing. There is no mention of AI, ML, or any learning algorithms.
No.
The device is intended for "removal of unwanted body hair" and "hair reduction," which are cosmetic purposes rather than treating or preventing medical conditions.
No
The device's intended use is for "removal of unwanted body hair," which is a treatment, not a diagnostic process.
No
The device description explicitly details hardware components such as a Xenon lamp, skin sensor, external power adapter, finger switch, and an ice compress function. It also mentions different models with variations in physical characteristics like spot size and display form. While software verification and validation are mentioned, the core functionality and operation rely on physical hardware.
Based on the provided information, 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 for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal Device uses light energy applied externally to the body to reduce hair growth. It does not analyze any biological samples taken from the body.
- Intended Use: The stated intended use is "removal of unwanted body hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
Therefore, the function and intended use of this device clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Product codes
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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with ice compress function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
The IPL Hair Removal Device includes ZHF-IPL-II and ZHF-IPL-III two models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly in product appearance and its spot size of the treatment window, output energy, and display form, but these differences do not affect or change the intended use of the device. The model difference is embodied in #1) the spot size of the ZHF-IPL-II is 3.6cm2 and the corresponding output energy is 2.64.4J/cm²; the spot size of the ZHF-IPL-III is 4.1cm² and the corresponding output energy is 2.43.7J/cm²; #2) the display form of ZHF-IPL-II is LCD display screen and indicator light, and the display form of ZHF-IPL-III is indicator bar and light.
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
end user. / over-the-counter
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
- Biocompatibility Safety: The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation 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 Sep. 4, 2020", 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: 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 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment.
- 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, the subject device IPL Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics
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.
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 28, 2022
Shenzhen Goodwind Technology Development CO., LTD % Rain Yip Registration engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address
Re: K222316
Trade/Device Name: IPL Hair Removal Device 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: July 12, 2022 Received: August 2, 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.
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
1
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,
Jianting Wang Acting 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
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Indications for Use
510(k) Number (if known) K222316
Device Name
IPL Hair Removal Device, Models: ZHF-IPL-II, ZHF-IPL-III.
Indications for Use (Describe)
The 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: 2022-07-12
I. Submitter
Shenzhen Goodwind Technology Development CO., LTD
4th&5Th Floor,2nd Part Of Building A1, Yinlong Industrial Park, Gate 292, Longgang Section Of Shenshan Road, Longdong Community, Longgang District, Shezhen Guangdong, CN Post code: 518116
Tel.: +86 138 0228 3843
Ziming Yang
Technical director
Tel: +86 138 0228 3843
Email: admin@goodwind.com.cn
II. Device
Name of Device: IPL Hair Removal Device
Model(s): ZHF-IPL-II, ZHF-IPL-III
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:
510(k) number: K221001
Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd.
Trade name: IPL Home Use Hair Removal Device, D-1198
Product code: OHT
Clearance date: May 12, 2022
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, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
4
The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with ice compress function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
The IPL Hair Removal Device includes ZHF-IPL-II and ZHF-IPL-III two models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly in product appearance and its spot size of the treatment window, output energy, and display form, but these differences do not affect or change the intended use of the device. The model difference is embodied in #1) the spot size of the ZHF-IPL-II is 3.6cm2 and the corresponding output energy is 2.64.4J/cm²; the spot size of the ZHF-IPL-III is 4.1cm² and the corresponding output energy is 2.43.7J/cm²; #2) the display form of ZHF-IPL-II is LCD display screen and indicator light, and the display form of ZHF-IPL-III is indicator bar and light.
V. Indications for Use
The 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 subject device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device 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 subject device may be found substantially equivalent to its predicate device.
The subject device is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance:
| Comparison
| Elements | Subject Device | Predicate device K221001 |
|---|---|---|
| K Number | K222316 | K221001 |
| Trade name | IPL Hair Removal Device/ZHF- | |
| IPL-II, ZHF-IPL-III | IPL Home Use Hair Removal | |
| Device/D-1198 | ||
| Wavelength range | 510-1100nm | 530-1100nm |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Energy density | ZHF-IPL-II: 2.6~4.4J/cm² | |
| ZHF-IPL-III: 2.4~3.7J/cm² | 2.0~4.3J/cm² | |
| Spot size | ZHF-IPL-II: 3.6cm² | |
| ZHF-IPL-III: 4.1cm² | 2.7cm² | |
| Pulse duration | 7.2~10.8ms | 5~12ms |
| Pulsing control | Finger switch | Finger switch |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue |
| Indication | ||
| for | The IPL Hair Removal Device is | IPL Home Use Hair Removal |
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| Comparison
| Elements | Subject Device | Predicate device K221001 |
|---|---|---|
| use/Intended use | an over-the-counter device intended for removal of unwanted body hair. | Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. |
| Location for use | OTC | OTC |
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Safety
The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation 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 Sep. 4, 2020", 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
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 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment
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, 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
6
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 device.