(134 days)
Not Found
No
The document describes a standard IPL hair removal device and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
Yes
The device is indicated for permanent reduction in hair regrowth, which is a therapeutic effect. It uses Intense Pulsed Light (IPL) to achieve this result, working below the skin's surface to reduce hair growth.
No
Explanation: The device is indicated for hair removal and permanent hair regrowth reduction using Intense Pulsed Light (IPL) technology. Its purpose is therapeutic/cosmetic, not to diagnose a disease, condition, or state of being.
No
The device description explicitly states it is a "portable device" and includes physical components like an "IPL DEVICE, Power supply and User manual." It also details physical characteristics like weight and size, and mentions electrical and biological safety testing, indicating it is a hardware device that utilizes Intense Pulsed Light technology.
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, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The IPL HAIR REMOVAL Device (Model: TFDA06S) uses Intense Pulsed Light to target hair follicles and reduce hair growth. It works on the surface of the skin and does not involve analyzing any biological specimens taken from the body.
- Intended Use: The intended use is for hair removal and permanent reduction in hair regrowth, which is a cosmetic or aesthetic procedure, not a diagnostic one.
- Testing: The non-clinical testing mentioned includes electrical safety, electromagnetic compatibility, and biological evaluation (cytotoxicity, irritation, sensitization), which are standard tests for medical devices that interact with the body, but not specifically for IVDs. The mention of ISO 10993-5 (In Vitro Cytotoxicity) might seem relevant, but this standard is for evaluating the biological response of cells to a medical device, not for diagnosing a condition using a biological sample.
In summary, the device's function, intended use, and testing described clearly indicate it is a medical device for hair removal, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OHT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Prescription home-use device. Intended for use under the direction of a physician, after training by a healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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3
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:
4
3. Predicate Device Information
| Sponsor | Medical Device Branch of Zhangzhou
Easepal Industrial Co.,Ltd. | Kam Yuen Plastic Products Ltd. |
|----------------------|-------------------------------------------------------------------|--------------------------------|
| Device Name | IPL Salon Hair Reduction System | Aimanfun Lumea Comfort |
| 510(k) Number | K181568 | K190820 |
| Regulation
Number | 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.
5
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 of
Comparison | Subject Device | Predicate Device I
(Primary) | Predicate Device (II) | Remark |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device Name
and Model | IPL HAIR REMOVAL,
Model: TFDA06S | IPL Salon Hair Reduction
System, Model: F60001 | Aimanfun Lumea Comfort
(Model: A-2788) | -- |
| 510(k) Number | K211174 | K181568 | K190820 | -- |
| Manufacturer | Shenzhen Qiaochengli
Technology Co., Ltd. | Medical Device Branch of
Zhangzhou Easepal
Industrial Co., Ltd. | Kam Yuen Plastic Products
Ltd. | -- |
| 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. | The IPL Salon Hair
Reduction System (Model:
F60001) is an over the
Counter device intended
for the removal of
unwanted body and/or
facial hair in adults. It is
also intended for
permanent reduction in
unwanted hair.
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. | The Aimanfun Lumea
Comfort (Model: A-2788) is
indicated for patient
removal of unwanted hair
by using a selective
photothermal treatment
under the direction of a
physician, after training by
a healthcare professional.
The Aimanfun Lumea
Comfort is also intended
for permanent reduction in
unwanted hair. Permanent
hair reduction is defined as
the long-term stable
reduction in the number of
hairs regrowing when
measured at 6. 9. and 12 | Same |
| Elements of
Comparison | Subject Device | Predicate Device I
(Primary) | Predicate Device (II) | Remark |
| | | | months after the
completion of a treatment
regimen. | |
| Source Energy | Supplied by external
adapter | Supplied by external
adapter | Supplied by external
adapter | Same |
| 'Use'
Classification | Prescription use | OTC | Prescription use | Same |
| Device
Classification | Class II | Class II | Class II | Same |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Wavelength (nm) | 470nm1200nm | 475nm1200nm | 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 |
| 60601Complianc
e with Voluntary
Standards | Yes
Comply with IEC 60601-1
and IEC 60601-1-2,
IEC60601-2-57 | Yes
Comply with IEC 60601-1
and IEC 60601-1-2,
IEC60601-2-57 | Yes
Comply with IEC
60601-1 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 |
6
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.