(134 days)
The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
IPL HAIR REMOVAL, Model: TFDA06S, a portable device, is a prescription home-use device for the permanent reduction of hair growth based on 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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission activation is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 260g, and the size is 185.4 x 68.5 x 41.4mm (HWD). The device adopts the international photonic beauty IPL technology. The purpose of the light is to heat the root where the hair grows.
This document is a 510(k) Summary for an IPL Hair Removal device (Model: TFDA06S). It details the device's substantial equivalence to predicate devices, primarily through non-clinical testing. It does not involve a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement, or complex ground truth establishment as would be present in an AI/ML-driven medical device submission.
Therefore, many of the requested points are not applicable to this document. I will answer the applicable points and explicitly state when information is not present.
Acceptance Criteria and Device Performance for IPL Hair Removal Device (Model: TFDA06S)
This submission primarily relies on comparing the subject device to legally marketed predicate devices through non-clinical testing to establish substantial equivalence, rather than a clinical study demonstrating performance against specific acceptance criteria for diagnostic accuracy or human-AI interaction.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly the safety and performance characteristics of the predicate devices. The "reported device performance" is the demonstration of similar characteristics and compliance with relevant safety standards.
| Acceptance Criteria (Implicit by Predicate Equivalence) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Electrical Safety (IEC 60601-1, IEC60601-1-11, IEC 60601-2-57) | Complies with IEC 60601-1, IEC60601-1-11, IEC 60601-2-57 standards |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 standard |
| Biocompatibility (Cytotoxicity - ISO 10993-5) | Complies with ISO 10993-5:2009/(R) 2014 |
| Biocompatibility (Irritation & Skin Sensitization - ISO 10993-10) | Complies with ISO 10993-10:2010 |
| Software Verification & Validation (FDA Guidance) | Software verification and validation test according to FDA guidance satisfied |
| Wavelength (similar to predicates) | 470nm |
| Max. Fluence (similar to predicates) | Max 4.83 J/cm² (Predicates: Max 5.0 J/cm², Max 4.5 J/cm²) |
| Spot Size (similar to predicates) | 3 cm² (Predicates: 1.72 cm² or 3.02 cm², 3.0 cm²) |
| Pulse Duration (similar to predicates) | 11-12 ms (Predicates: 11-12 ms, 3 milliseconds) |
| Energy Medium (similar to predicates) | Xenon Arc Flashlamp (Same as predicates) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document states: "Clinical testing: No clinical trial is necessary in the submission." Therefore, there is no "test set" in the context of clinical data for performance evaluation as would be seen for an AI/ML device. The "testing" refers to bench testing for electrical safety, EMC, biocompatibility, and software V&V. The provenance of this bench testing data is not specified beyond being "evaluated... by lab bench testing."
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. As no clinical trial or AI/ML performance study was conducted, there was no need for expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
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/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical accuracy for an AI/ML device. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the specifications outlined in the referenced IEC and ISO standards.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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September 1, 2021
Shenzhen Qiaochengli Technology Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District GuangZhou, Guangdong China
Re: K211174
Trade/Device Name: IPL Hair Removal 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 18, 2021 Received: July 23, 2021
Dear Jet Li:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211174
Device Name IPL HAIR REMOVAL
Indications for Use (Describe)
The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician, after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Type of Use (Select one or both, as applicable)
| ☒ Exportation (Part 374.9(a) Statement Required) | □ Solely to Service/Repair (374.3(b)) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Shenzhen Qiaochengli Technology Co., Ltd. IPL HAIR REMOVAL, Model: TFDA06S Subject Device: K211174 510(k) number:
510(k) Summary
Date of the summary prepared: August 27, 2021
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor
- � Company Name: Shenzhen Qiaochengli Technology Co., Ltd.
- Address: 501-5, rujun building, 105 Zhongxing Road, Ma'antang community, Bantian street, � Longgang District, Shenzhen City, Guangdong Province,China
- Phone: +86-0755-23072580 �
- Fax: +86-0755-23072580 �
- � Contact Person (including title): LiPing Zhou
- � E-mail: 2323980316@qq.com
Application Correspondent:
- Company Name: Guangzhou KEDA Biological Tech Co., Ltd. �
- � Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
- Contact Person: Mr. Jet Li �
- Tel: +86-18588874857 �
- � Email: Med-jl@foxmail.com
Subject Device Information 2.
- IPL HAIR REMOVAL, Model: TFDA06S Trade Name: �
- Powered Light Based Non-Laser Surgical Instrument With � Common Name:
- Thermal Effect
- Laser Surgical Instrument For Use In General And Plastic Classification name: � Surgery And Dermatoloty
- � Review Panel: General & Plastic Surgery
- ONF Product Code: �
- 2 Regulation Class: �
- 878.4810 � Regulation Number:
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3. Predicate Device Information
| Sponsor | Medical Device Branch of ZhangzhouEasepal Industrial Co.,Ltd. | Kam Yuen Plastic Products Ltd. |
|---|---|---|
| Device Name | IPL Salon Hair Reduction System | Aimanfun Lumea Comfort |
| 510(k) Number | K181568 | K190820 |
| RegulationNumber | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 |
4. Device Description
IPL HAIR REMOVAL, Model: TFDA06S, a portable device, is a prescription home-use device for the permanent reduction of hair growth based on 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. It is a personal Light-Based Hair Removal System. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Emission activation is by finger switch. Device includes IPL DEVICE, Power supply and User manual. It is used AC Powered (100-240 V AC). The weight of the device is 260g, and the size is 185.4 x 68.5 x 41.4mm (HWD). The device adopts the international photonic beauty IPL technology. The purpose of the light is to heat the root where the hair grows.
5. Indications for Use
The IPL HAIR REMOVAL Device (Model: TFDA06S) is indicated for the removal of unwanted hair under the direction of a physician,after training by a healthcare professional. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
6. Test Summary
Non clinical testing:
IPL HAIR REMOVAL (Model: TFDA06S) has been evaluated the safety and performance by lab bench testing as following:
- � Electrical safety test according to IEC 60601-1, IEC60601-1-11 and IEC 60601-2-57 standards
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � ISO 10993-5:2009/(R) 2014, 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.
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Shenzhen Qiaochengli Technology Co., Ltd. Sponsor: IPL HAIR REMOVAL, Model: TFDA06S Subject Device: 510(k) number: K211174
- � Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"
Clinical testing: No clinical trial is necessary in the submission.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of IPL HAIR REMOVAL (Model: TFDA06S) is substantially equivalent to the predicate devices quoted above.
The Substantial equivalence decision was based on the following comparison with the predicate devices:
| Elements ofComparison | Subject Device | Predicate Device I(Primary) | Predicate Device (II) | Remark |
|---|---|---|---|---|
| Device Nameand Model | IPL HAIR REMOVAL,Model: TFDA06S | IPL Salon Hair ReductionSystem, Model: F60001 | Aimanfun Lumea Comfort(Model: A-2788) | -- |
| 510(k) Number | K211174 | K181568 | K190820 | -- |
| Manufacturer | Shenzhen QiaochengliTechnology Co., Ltd. | Medical Device Branch ofZhangzhou EasepalIndustrial Co., Ltd. | Kam Yuen Plastic ProductsLtd. | -- |
| Indications forUse | The IPL HAIR REMOVALDevice (Model: TFDA06S)is indicated for the removalof unwanted hair under thedirection of a physician,after training by ahealthcare professional.The device is alsoindicated for the permanentreduction in hair regrowth,defined as the long-term,stable reduction in thenumber of hairs re-growingwhen measured at 6, 9 and12 months after thecompletion of a treatmentregime. The device is usedfor adults. | The IPL Salon HairReduction System (Model:F60001) is an over theCounter device intendedfor the removal ofunwanted body and/orfacial hair in adults. It isalso intended forpermanent reduction inunwanted hair.Permanent hair reductionis defined as the long-termstable reduction in thenumber of hairs re-growingwhen measured at 6. 9.And 12 months after thecompletion of a treatmentregimen. | The Aimanfun LumeaComfort (Model: A-2788) isindicated for patientremoval of unwanted hairby using a selectivephotothermal treatmentunder the direction of aphysician, after training bya healthcare professional.The Aimanfun LumeaComfort is also intendedfor permanent reduction inunwanted hair. Permanenthair reduction is defined asthe long-term stablereduction in the number ofhairs regrowing whenmeasured at 6. 9. and 12 | Same |
| Elements ofComparison | Subject Device | Predicate Device I(Primary) | Predicate Device (II) | Remark |
| months after thecompletion of a treatmentregimen. | ||||
| Source Energy | Supplied by externaladapter | Supplied by externaladapter | Supplied by externaladapter | Same |
| 'Use'Classification | Prescription use | OTC | Prescription use | Same |
| DeviceClassification | Class II | Class II | Class II | Same |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Wavelength (nm) | 470nm~1200nm | 475nm~1200nm | 475~1200nm | Similar |
| Max. Fluence(J/cm²) | Max 4.83 [Joules/cm²] | Max 5.0 [Joules/cm²] | Max 4.5 [Joules/cm²] | Similar |
| Spot Size (cm2) | 3 cm² | 1.72 cm² or 3.02 cm² | 3.0 cm² | Same |
| Pulse duration | 11-12 ms | 11-12 ms | 3 milliseconds | Same |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| 60601Compliance with VoluntaryStandards | YesComply with IEC 60601-1and IEC 60601-1-2,IEC60601-2-57 | YesComply with IEC 60601-1and IEC 60601-1-2,IEC60601-2-57 | YesComply with IEC60601-1 and IEC 60601-1-2,IEC60601-2-57 | Same |
| Weight | 260g | 650g | 200g | Similar |
| Dimensions | 185.468.541.4 mm(HWD) | 14369.543mm(HWD) | 138.98247.3mm(HWD) | Similar |
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Sponsor: Shenzhen Qiaochengli Technology Co., Ltd. Subject Device: IPL HAIR REMOVAL, Model: TFDA06S 510(k) number: K211174
Finial Conclusion:
Based on the nonclinical testing conducted, the subject device "IPL HAIR REMOVAL, Model: TFDA06S" 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.