(60 days)
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device 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.
IPL Hair Removal Device (Models:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-use device for hair reduction by using Intense Pulsed Light (IPL). It 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. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
IPL Hair Removal Device, models:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.
This document is a 510(k) Summary for an IPL Hair Removal Device. It is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device. This type of document does not contain studies on device performance in the way an academic paper or a clinical trial report would, especially regarding specific "acceptance criteria" and "reported device performance" in terms of clinical effectiveness for hair removal.
Instead, the "performance data" section focuses on safety and regulatory compliance rather than clinical efficacy metrics. It confirms that the device meets safety standards (biocompatibility, electrical safety, EMC, eye safety) and software validation requirements.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly answered from this regulatory summary.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present clinical acceptance criteria for hair removal efficacy (e.g., percentage reduction in hair regrowth) or reported device performance against such criteria. The "performance data" section focuses on safety and engineering standards.
| Acceptance Criteria Type (as inferred for regulatory compliance) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility (Cytotoxicity) | Passed ISO 10993-5:2009 |
| Biocompatibility (Irritation & Skin Sensitization) | Passed ISO 10993-10:2010 |
| Electrical Safety (General) | Passed ANSI AAMI ES60601-1 |
| Electrical Safety (EMC) | Passed IEC 60601-1-2 |
| Electrical Safety (Home Healthcare) | Passed IEC 60601-1-11 |
| Electrical Safety (Home Light Therapy) | Passed IEC 60601-2-83 |
| Eye Safety | Passed IEC 62471 |
| Software Verification & Validation | All software requirement specifications met, all software hazards mitigated to acceptable risk levels. Consistent with moderate level of concern. |
| Usability | Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For Biocompatibility, Electrical Safety, Eye Safety, and Software Validation: These tests are typically performed on a limited number of device units or components in a laboratory setting. The specific "sample size" of devices or components tested is not provided, but it would not be a "test set" of patient data. The provenance for these engineering and safety tests is typically the manufacturing environment or a third-party testing lab. The document confirms these were conducted by a "reliable third-party lab" (for biocompatibility).
- For Clinical Hair Removal Efficacy: This document does not describe any clinical study for hair removal efficacy with a patient test set. The claim for "permanent reduction in hair regrowth" is listed under "Indications for Use," which implies it is an intended function, but the document does not include data from a study directly demonstrating this on a test set for this specific device. It relies on substantial equivalence to predicate devices which have likely demonstrated this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a clinical study for which a ground truth based on expert consensus would be established for a human test set. For the engineering and safety tests, the "ground truth" is adherence to established international standards, verified by testing specialists at accredited labs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human test set or clinical study requiring adjudication is detailed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/imaging device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical IPL device. "Standalone performance" in this context refers to the device operating according to its design specifications regarding light emission, safety features, etc., which is covered by the safety and engineering tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For safety and engineering tests: The "ground truth" is compliance with international standards (e.g., ISO 10993, IEC 60601, IEC 62471) as verified by laboratory measurements and procedures.
- For hair removal efficacy: While "permanent reduction in hair regrowth" is stated in the Indications for Use, which would typically require clinical outcomes data or expert assessment in a clinical trial to establish, this document does not present such data for this specific device. It relies on the substantial equivalence to predicate devices, implying those predicate devices have acceptable evidence for this claim.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning or AI model that would require a "training set." The "software" mentioned is for operational control and safety features, not for learning from data related to hair removal.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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September 22, 2023
Shenzhen Koli Technology Co.,Ltd % Yvonne Liu 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: K232183
Trade/Device Name: IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 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 24, 2023 Received: July 24, 2023
Dear Yvonne Liu:
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
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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 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.
Tanisha L. Hithe -S Tanisha L. 2023.09.22 Hithe -S 14:53:36 -04'00'
Tanisha Hithe, MS, MHS 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) K232183
Device Name IPL Hair Removal Device Model(s): T1, T2, T3, T7, T10
Indications for Use (Describe)
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device 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.
Type of Use (Select one or both, as applicable)
| Registration Use (Part 34 CFR 301 Subpart D) | |
|---|---|
| On-The-Spot-Use (34 CFR 301 Subpart C) |
__ 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 K232183
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Shenzhen Koli Technology Co.,Ltd Floor 4, No.145-1 Furui Road, Xintian Community, Fuhai Street, Bao'an District, Shenzhen, China Post code: 518103 Tel.: +86 15818667227 Fu Qizhen General Manager Tel: +86 15818667227 Email: fuqizhen1983@163.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): T1, T2, T3, T7, T10 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 Device and reference device
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Ishine TechnologyCompany Limited | IPL Hair Removal Device,Model(s):skn001,skn005,skn006,skn002,RoseSkinCo Lumi | K222537 | Oct 14,2022 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Beauty EveryMoment intelligent electricCo.,Ltd | IPL Home Use Hair RemovalDevice, Models: D-1198, D-1185, D-1186, D-1189, D-1197 | K221001 | May 12, 2022 |
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IV. Device Description
IPL Hair Removal Device (Models:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-use device for hair reduction by using Intense Pulsed Light (IPL). It 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. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
IPL Hair Removal Device, models:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.
V. Indications for Use
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device 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.
VI. Materials
| Componentname | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL HairRemoval Device(Enclosure andflash window) | ABS, PC,POM | 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 Hair Removal 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 and reference 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 and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device and reference device.
IPL Hair Removal Device is compared with the following Predicate Device and Reference Device in terms of intended use, design, material,specifications, and performance:
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| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k)Number | Pending | K222537 | K221001 | / |
| Trade name | IPL Hair Removal DeviceT1,T2,T3,T7,T10 | IPL Hair Removal Device(skn001,skn005,skn006,skn002,RoseSkin Co Lumi) | IPL Home Use HairRemoval Device,Models: D-1198, D-1185, D-1186, D-1189,D-1197 | / |
| Manufacturer | Shenzhen Koli TechnologyCo.,Ltd | SHENZHENTECHNOLOGYCOMPANY LIMITED | Shenzhen Beauty EveryMoment intelligent /electric 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 | IPL Hair Removal Deviceis indicated for the removalof unwanted hair. Thedevice is also indicated forthe permanent reduction inhair regrowth, defined asthe long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime. | IPL Hair Removal Deviceis indicated for the removalof unwanted hair. Thedevice is also indicated forthe permanent reduction inhair regrowth, defined asthe long-term, stablereduction in the number ofhairs regrowing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregime. | IPL Home Use HairRemoval Device is anover-the counter deviceintended for removal ofunwanted body and /orfacial hair | Same |
| Prescriptionor OTC | OTC | OTC | OTC | Same |
| Sourceenergy | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | Same |
| PowerSupply | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | Unknown | Same |
| Dimension | T1: 176 x 62 x 35mmT2: 171 x 64 x 34mmT3: 214 x 63 x 64mmT7: 174 x 63 x 36mm | skn001:1348348.5mmskn005:132.58348mmskn006:135.58652.5mmskn002:1348240mm | Unknown | Different |
| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
| T10: 171 x 64 x 35mm | RoseSkinCo1348240mm | Lumi: | ||
| Weight | T1: 200gT2: 296gT3: 200gT7: 216gT10: 216g | skn001:196gskn005: 196gskn006: 210gskn002: 186gRoseSkinCo Lumi:186g | Unknown | Different |
| Sterilization | Not required | Not required | Not required | Same |
| Light Source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energymedium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelengthrange | 510-1100nm | 510-1100nm | 550-1100nm | Same |
| SpotSize( cm² ) | T1: $3.0 \pm 0.25cm^2$T2: $3.9 \pm 0.25cm^2$T3: $3.2 \pm 0.25cm^2$T7: $3.0 \pm 0.25cm^2$T10: $3.9 \pm 0.25cm^2$ | $3.3cm^2$ | D-1198: $2.7 cm^2$D-1185: $2.7 cm^2$D-1186: $3.0 cm^2$D-1189: $3.0 cm^2$D-1197: $3.4 cm^2$ | Similar |
| EnergyDensity(±20%) | T1,T7: 1.33 | For sk001,skn005,skn006Level 1: 1.5 J/cm²Level 2: 1.9J/cm²Level 3: 2.3J/cm²Level 4: 2.8J/cm²Level 5: 3.5J/cm²For skn002and RoseSkinCo LumiLevel 1: 1.6J/cm²Level 2: 1.9J/cm²Level 3: 2.3J/cm²Level 4: 2.8J/cm²Level 5: 3.2J/cm²Level 6: 3.8J/cm² | 2.0~4.3 J/cm² | Similar |
| Pulseduration | 4-12ms | 6-8ms | 5-12 ms | Similar |
| ComparisonElements | Subject Device | Predicate Device | Reference Device | Remark |
| Pulsingcontrol | Finger switch | Finger switch | Finger switch | Same |
| Numberofoutputchannels | One channel | One channel | One channel | Same |
| Outputintensitylevel | 5 Levels | Levels5forskn001,skn005,skn006;6Levels for skn002andRoseSkinCo Lumi | Unknown | Similar |
| Skin ContactSensor | Yes | Yes | Yes | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Same |
| Electricalsafety | ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83 | IEC 60601-1-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 | Same |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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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 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 –Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
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2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per 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
-
ANSI AAMI ES60601-1 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.
5) Usability
The product usability has been evaluated and verified according to the following FDA guidance > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device and reference device.
§ 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.