(59 days)
The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
The provided text is a 510(k) summary for an IPL Cooling Hair Removal Device. It details the device's characteristics, comparison to predicate devices, and performance data from non-clinical tests. However, it does not include a study proving the device meets acceptance criteria in terms of clinical efficacy (e.g., hair removal effectiveness).
The "Performance Data" section primarily focuses on non-clinical aspects:
- Biocompatibility Testing: Confirms the materials are safe for body contact.
- Electrical Safety and EMC: Ensures the device meets electrical safety and electromagnetic compatibility standards.
- Eye Safety: Indicates compliance with photobiological safety standards.
- Software Verification and Validation: Verifies the software functions as intended and mitigates risks.
There is no mention of a clinical study or specific acceptance criteria for hair removal efficacy (such as a target percentage of hair reduction). The substantial equivalence is based on the device having the "same intended use, mode of action and similar operational characteristics as the predicate devices" and that "Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy." The performance data provided supports the safety and general operation of the device, rather than its clinical effectiveness in hair removal.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for clinical efficacy cannot be extracted from this document, as such a study and criteria are not detailed.
However, based on the provided document, I can describe the non-clinical performance data and the context of the substantial equivalence determination:
Summary of Non-Clinical Performance Data for IPL Cooling Hair Removal Device (K230360)
This 510(k) submission establishes substantial equivalence for the IPL Cooling Hair Removal Device based on non-clinical performance data, primarily focusing on safety and technical specifications compared to predicate devices. There is no clinical study presented in this document that proves the device meets specific acceptance criteria for hair removal efficacy.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Standard/Test (Acceptance Criteria) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) | Passed |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | Passed | |
| Electrical Safety & EMC | ANSI AAMI ES60601-1 (Medical electrical equipment) | Passed |
| IEC 60601-1-2 (Electromagnetic disturbances) | Passed | |
| IEC 60601-1-11 (Home Healthcare Environment) | Passed | |
| IEC 60601-2-83 (Home light therapy equipment) | Passed | |
| Eye Safety | IEC 62471 (Photobiological safety of lamps) | Passed |
| Software | System validation testing (all software requirements met, hazards mitigated) | Demonstrated compliance |
| Technical Specifications (Comparison to Predicates) | Energy density within predicate range (Note 2) | Complies with IEC 60601-2-83 and IEC 62471 requirements |
| Output energy within predicate range (Note 2) | Complies with IEC 60601-2-83 and IEC 62471 requirements | |
| Pulse duration within predicate range (Note 3) | Complies with IEC 60601-2-83 and IEC 62471 requirements |
2. Sample Size Used for the Test Set and Data Provenance
- For Biocompatibility, Electrical Safety, EMC, Eye Safety, Software Validation: The document does not specify sample sizes for these tests. It indicates that testing was performed and passed according to the referenced standards. This type of testing typically involves standardized protocols on product samples or component materials rather than human subjects.
- Data Provenance: The document does not explicitly state the country of origin for the testing facilities. It mentions "reliable third-party lab" for biocompatibility. The submission itself is from "Shenzhen Jizhimei Technology Co., Ltd." in China. The testing described is non-clinical/pre-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for these non-clinical tests. The "ground truth" for biocompatibility, electrical safety, etc., is defined by the international standards themselves, and the testing laboratories verify compliance to these standards.
4. Adjudication Method for the Test Set
Not applicable for these non-clinical tests. Compliance is determined by whether the device's performance meets the quantitative or qualitative requirements specified in the relevant international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was mentioned or performed as this report does not contain any clinical efficacy data. The substantial equivalence is based on technical and safety comparisons, not clinical performance metrics involving human readers.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a hardware product relying on physics (Intense Pulsed Light) for its function, not an algorithm requiring standalone performance evaluation in the context of AI/software interpretation. The "Software Verification and Validation" section confirms the device's internal software functions correctly and safely, which is a component of its standalone operation rather than a separate AI algorithm evaluation.
7. Type of Ground Truth Used
- For Biocompatibility: Ground truth is established by the specified ISO 10993 standards.
- For Electrical Safety/EMC/Eye Safety: Ground truth is established by the specified IEC/ANSI standards.
- For Software: Ground truth is established by "software requirement specifications" and "acceptable risk levels."
8. Sample Size for the Training Set
Not applicable for this type of device and testing. There is no mention of a machine learning model or algorithm that requires a training set in the context typically discussed for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is mentioned.
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April 10, 2023
Shenzhen Jizhimei Technology Co., Ltd. % Riley Chen Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K230360
Trade/Device Name: IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 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: February 10, 2023 Received: February 10, 2023
Dear Riley Chen:
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.
Colin K. Chen -S
for
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) K230360
Device Name IPL Cooling Hair Removal Device Model(s): NBB01, NBB02
Indications for Use (Describe)
The IPL Cooling Hair Removal Device 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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510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Shenzhen Jizhimei Technology Co., Ltd. Building A203, Building A/B, Zone B, Gonghe Community, Shajing Street, Baoan District, Shenzhen, China Post code: 518100 Tel.: +86 0755-86953535
Guo Miaosi Legal representative Tel: +86 15976876862 Email: 794796654@qq.com
II. Device
Name of Device: IPL Cooling Hair Removal Device Model(s): NBB01, NBB02 Common or Usual 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: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Devices
Primary Predicate Device >
| Manufacturer | Primary Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen QianyuTechnology Co., Ltd. | Hand-held IPL device (JOVSHair Removal Device) | K220645 | April 27, 2022 |
Secondary Predicate Device >
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Ulike SmartElectronics Co.,Ltd | IPL Hair Removal Device,Model(s): UI04A, UI04B,UI04C | K221002 | June 1, 2022 |
IV. Device Description
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IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.
V. Indications for Use
The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
VI. Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL Cooling HairRemoval Device(Enclosure andlight exit) | PC, ABS | Surface-contactingdevice: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".
VII.Comparison of Technological Characteristics With the Predicate Device
The IPL Cooling Hair Removal Device (model: NBB01, NBB02) 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 subject device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Cooling Hair Removal Device may be found substantially equivalent to its predicate devices.
| ComparisonElements | Subject Device | Primary Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| 510(k)Number | K230360 | K220645 | K221002 | / |
| Trade name | IPL CoolingRemoval Device | Hand-held IPL device(JOVS HairRemoval Device) | IPL Hair RemovalDevice, Model(s):UI04A, UI04B, UI04C | / |
| ComparisonElements | Subject Device | Primary Predicate Device | Predicate Device | Remark |
| Manufacturer | Shenzhen JizhimeiTechnology Co., Ltd. | Shenzhen QianyuTechnology Co., Ltd. | Shenzhen Ulike SmartElectronics Co.,Ltd | |
| Regulationnumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Deviceclassification | Class II | Class II | Class II | Same |
| Indication foruse/ Intendeduse | The IPL Cooling HairRemoval Device is anover-the-counter deviceintended for removal ofunwanted body and/orfacial hair. | Hand-held IPL device(JOVS Hair RemovalDevice) is an over-the-counter device intended forremoval of unwanted bodyand/or facial hair. | IPL Hair RemovalDevice is indicated forthe removal of unwantedhair. The device is alsoindicated for thepermanent reduction inhair regrowth, defined asthe long-term, stablereduction in the numberof hairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime. | Same |
| Prescriptionor OTC | OTC | OTC | OTC | Same |
| Applicableskin | Fitzpatrick skin types I-V | Unknown | Fitzpatrick skin types I-V | Same |
| Source energy | 100-240V, 50/60Hz | Unknown | 100-240V, 50/60Hz | Same |
| Power supply | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | Same |
| Dimension | NBB01:47.654.3240 mmNBB02-MAX:2357643 mm | Unknown | 60.5(W)x38(H)x169.7(L)mm | DifferentNote 1 |
| Sterilization | No | No | No | Same |
| Wavelengthrange | 550-1200mm | 590nm~1200nm | 550-1200mm | Same |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energymedium | Xenon Arc Flashlamp | Xenon lamp | Xenon Arc Flashlamp | Same |
| Energydensity | 2 | 1.83~5.14J/cm² | 3.03-5.3J/cm² | SimilarNote 2 |
| ComparisonElements | Subject Device | Primary Predicate Device | Predicate Device | Remark |
| Output energy | Model NBB01:8 ~ 17.05JModel NBB02:7.14~13.62J | 6.4~18 J | 10~17.5J | SimilarNote 2 |
| Outputintensity level | NBB01: 5 levelsNBB02: 6 levels | Unknown | 5 levels | Similar |
| Spot size | 3.6cm2(applicableformodelNBB01andNBB02) | 3.5cm2 | 3.3cm2 | Similar |
| Pulse duration | 6.4-7.2ms | 5.5~9.5 ms | 7-10ms | SimilarNote 3 |
| Pulsingcontrol | Finger switch | Finger switch | Finger switch | Same |
| Deliverydevice | Direct illumination totissue | Direct illumination to tissue | Direct illumination totissue | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same |
| Biocompatibility | ISO10993-5ISO10993-10 | Unknown | ISO10993-5ISO10993-10 | Same |
| ElectricalSafety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1-2IEC 60601-1-11ANSI AAMI ES60601-1IEC 60601-2-57IEC 60601-2-83 | Same |
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Note 1:
Though the dimension is different from the predicate device, this difference is insignificant and do not raise any safety/effectiveness problems.
Note 2:
Though the energy density and the output energy of subject device is a little different from the primary predicate device, the energy density and the output energy of subject device is within the range of the minimum and maximum value of the primary predicate device, and the device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
Note 3:
Though the pulse duration of subject device is different from the primary predicate device, it's basically within the range of the primary predicate device, and the subject device complies with
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IEC IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
VIII. 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 IPL Cooling Hair Removal 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, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
-
ANSI AAMI ES60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
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.
IX. Conclusions
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Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Cooling Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 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.