(85 days)
The IPL Hair Removal Device (Model : AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.
IPL Hair Removal Device, models: Al01, Al06, Al08, Al16, Al17 are hand-held overthe-counter devices for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). The device is powered by an external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon arc flashlamp, a skin sensor to detect appropriate skin contact, and a skin color detection system to detect the skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The skin color detection system detects whether a skin tone is suitable for treatment. If the skin tone is not in the range suitable for treatment, the device is designed to not emit the treatment light pulses. The light pulses are selectively absorbed by the hair follicles, which results in the hair follicles being temporarily heated. This results in a reduction of hair growth from the treated hair follicles.
This document is a 510(k) summary for an IPL Hair Removal Device. The standard details for describing acceptance criteria and clinical study results typical of an AI/ML medical device submission are not available in this document because:
- It is not an AI/ML medical device. The device is an Intense Pulsed Light (IPL) hair removal device, which is a physical device rather than an AI/ML algorithm.
- It is not a clinical study report. This document is a premarket notification (510(k) summary) whose purpose is to demonstrate substantial equivalence to a legally marketed predicate device, not to report a comprehensive clinical trial.
- It explicitly states "There was no clinical testing performed." This immediately negates the possibility of providing information on acceptance criteria based on clinical performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance.
Therefore, the requested information elements cannot be extracted from the provided text for the following reasons:
1. A table of acceptance criteria and the reported device performance:
* No clinical acceptance criteria are provided because no clinical testing was performed. The "performance" section refers to non-clinical testing against recognized standards (e.g., electrical safety, EMC, biocompatibility), not clinical efficacy metrics.
2. Sample size used for the test set and the data provenance:
* Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. No clinical test set or ground truth establishment relevant to AI performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable.
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-assisted device, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. There is no AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable. No clinical ground truth was established for performance evaluation.
8. The sample size for the training set:
* Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
* Not applicable.
Summary of available information related to performance/testing:
The document focuses on non-clinical testing to ensure safety and essential performance of the physical device and its electrical/biocompatibility aspects.
- Non-Clinical Tests Performed: The device underwent testing to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance)
- IEC 60601-1-2: 2014 (Electromagnetic Disturbances)
- IEC 60601-1-11: 2015 (Medical Electrical Equipment for home healthcare environment)
- ISO 60601-2-57: 2011 (Basic safety and essential performance of non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
- IEC 62471: 2006 (Photobiological safety of lamps and lamp systems)
- ISO 10993-5:2009 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)
- IEC 62304:2006+A1:2015 (Medical device software - Software life cycle processes)
- Results: All listed non-clinical tests passed.
- Safety Features: The device includes a skin sensor for contact detection and a skin color detection system to prevent light emission if skin tone is unsuitable.
The purpose of this 510(k) was to demonstrate substantial equivalence, relying on non-clinical engineering and safety standards, rather than clinical performance data.
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August 12, 2022
Shenzhen Century Dongyuan Technology Co Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C. Run Science Park, No.18 Shenzhou Road, Huangpu Guangzhou, Guangdong 510663 China
Re: K221466
Trade/Device Name: IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 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: May 19, 2022 Received: May 19, 2022
Dear You Yijie:
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,
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)
Device Name
IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
Indications for Use (Describe)
The IPL Hair Removal Device (Model : AI01, AI06, AI16, AI17) is intended for the 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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Section 5: 510(K) Summary
1. Submitter's Information
| Establishment Registration Information: | |
|---|---|
| Name: | Shenzhen Century Dongyuan Technology Co Ltd. |
| Address: | Floor 2, Building B1, Gonghe Fourth Industrial Zone,Shajing Street, Bao'an District, Shenzhen City,Guangdong Province China |
| Contact Person of applicant: | |
| Name: | He Wang |
| Address: | Floor 2, Building B1, Gonghe Fourth IndustrialZone, Shajing Street, Bao'an District, ShenzhenCity, Guangdong Province China |
| TEL: | +86 13798450554 |
| Email: | aijofi01@163.com |
| Contact Person of the Submission: | |
| Name: | You Yijie |
| Address: | RM.406, Building C, Run Science Park, No.18Shenzhou Road, Huangpu, Guangzhou,Guangdong 510663 P.R.China |
| TEL: | (+86)020-82245821 |
|---|---|
| FAX: | (+86)020-82245821 |
| Email: | jet.you@qimmiq-med.com |
Date prepared: May 13, 2022
2. Device Information
| Trade Name: | IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 |
|---|---|
| Classification name: | Light Based Over-The-Counter Hair Removal |
| Common or Usual Name: | Powered Light Based Non-Laser Surgical Instrument WithThermal Effect |
| Review panel: | General & Plastic Surgery |
| Product code: | OHT |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
3. Predicate Device Information
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| 510(k) submitter/holder: | Shenzhen Century Dongyuan Technology CoLtd. |
|---|---|
| 510(K) Number: | K212897 |
| Trade Name: | IPL Hair Removal Device |
| Model: | AI01 |
| Classification name: | Powered Light Based Non-Laser SurgicalInstrument With Thermal Effect |
| Review panel: | General & Plastic Surgery |
| Product code: | ONF |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
4. Device description
IPL Hair Removal Device, models: Al01, Al06, Al08, Al16, Al17 are hand-held overthe-counter devices for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). The device is powered by an external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon arc flashlamp, a skin sensor to detect appropriate skin contact, and a skin color detection system to detect the skin color. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses. The skin color detection system detects whether a skin tone is suitable for treatment. If the skin tone is not in the range suitable for treatment, the device is designed to not emit the treatment light pulses. The light pulses are selectively absorbed by the hair follicles, which results in the hair follicles being temporarily heated. This results in a reduction of hair growth from the treated hair follicles.
5. Indications for Use
The IPL Hair Removal Device (Model: AI01, AI06, AI08, AI16, AI17) is intended for the removal of unwanted body hair.
6. Summary of technological characteristics of device
| SEComparisons | Subject device(IPL Hair Removal Device,model: Al01, Al06, Al08, Al16, Al17) | Predicate device(IPL Hair Removal Device,model: Al01) | Discussion ofdifference |
|---|---|---|---|
| 510K Number | / | K212897 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | OHT | ONF | TechnicalMethodequivalent, havesameClassificationregulation |
compared to the predicate devices (K212897)
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| FDA Class | II | II | Same |
|---|---|---|---|
| Model | AI01, AI06, AI08, AI16, AI17 | AI01 | / |
| Indications for Use | The IPL Hair Removal Device (Model:AI01, AI06, AI08, Al16, Al17) is intendedfor the removal of unwanted body hair. | The IPL Hair Removal Device(Model: Al01) is intended for the Same | |
| Type of use | Over-The-Counter Use | Prescription Use | Different |
| Design | Hand-held | Hand-held | Same |
| Patient Population | Adult | Adult | Same |
| Technology | Intense Pulse Light (IPL) | Intense Pulse Light (IPL) | Same |
| Dimensions | 14020356 | 14020356 | Same |
| Power source | an external power supply | an external power supply | Same |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | 510nm~1100nm | 510nm~1100nm | Same |
| Spot Size | 3.1 cm² | 3.1 cm² | Same |
| Max. Fluence(J/cm²) | 3.8-5.2 J/cm² | 3.8-5.2 J/cm² | Same |
| Pulse duration | 3 milliseconds | 3 milliseconds | Same |
| Output energy | 12-16 J | 12-16 J | Same |
| PulsingControl | Finger switch | Finger switch | Same |
| Skin contact sensor | Yes | Yes | Same |
| Skin Tone detection | Yes | No | Different |
| SoftwareControl | Yes | Yes | Same |
| Electricalsafety, EMC,BiologicalEvaluation | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471ISO 10993-5ISO 10993-10 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471ISO 10993-5ISO 10993-10 | Same |
7. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The modifications to the device have been designed and assessed under design control processes compliant with FDA 21 CFR 820. A risk analysis was conducted to assess the impact of the changes on the subject device using internal design control procedures and a fault tree analysis described in the FDA-recognized version of ISO 14971.
These risks were mitigated using planned measures that included testing to recognized FDA consensus standards. Changes in software were verified and validated using the software development process.
Non-clinical testing listed in the table below was performed to demonstrate that the device can be used safely and effectively for the proposed indications for use.
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| Standards | Standards Name | Results |
|---|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012 | Medical Electrical Equipment - Part 1:General Requirements For Basic SafetyAnd Essential Performance | Pass |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General Requirements For BasicSafety And Essential Performance --Collateral Standard: ElectromagneticDisturbances -- Requirements AndTests | Pass |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2:General Requirements For Basic SafetyAnd Essential Performance - CollateralStandard: ElectromagneticDisturbances - Requirements AndTests | Pass |
| ISO 60601-2-57: 2011 | Particular requirements for the basicsafety and essential performance ofnon-laser light source equipmentintended for therapeutic, diagnostic,monitoring and cosmetic/aesthetic use | Pass |
| IEC 62471: 2006 | Photobiological safety of lamps andlamp systems | Pass |
| ISO 10993-5:2009 | Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity | Pass |
| ISO 10993-10:2010 | Biological evaluation of medical devices- Part 10: Tests for irritation and skinsensitization | Pass |
| IEC62304:2006+A1:2015 | Medical device software - Software lifecycle processes | Pass |
8. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
9. Conclusions
The subject device IPL Hair Removal Device models Al01, Al06, Al08, Al16, and Al17, in this 510(k) use the same IPL technology that is used in the predicate device K212897. Differences between the subject device models and predicate device do not raise new types of questions regarding safety and effectiveness, and performance testing demonstrates that the proposed device can be used safely and effectively for the proposed indications for use. The proposed IPL Hair Removal Device is considered to be substantially equivalent to the predicate K212897 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.