(137 days)
Not Found
No
The description focuses on basic sensor inputs (skin color, proximity) and pulsed light technology, with no mention of AI/ML terms or complex data processing beyond simple checks.
No.
The device is intended for "permanent reduction in hair regrowth," which is a cosmetic improvement and not the treatment or diagnosis of a disease or condition. While it has a biological effect (disabling hair growth), it does not meet the definition of a therapeutic device designed to treat a medical illness or injury.
No
The device is described as a hair removal device intended for permanent reduction in hair regrowth. Its components and function are all geared towards treatment (hair removal) rather than diagnosis.
No
The device description explicitly states it is composed of a hand-held applicator and an external power supply, both of which are hardware components. It also mentions a xenon lamp, skin color sensor, and skin proximity sensor, further indicating a hardware-based device.
No, 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, tissue) to provide information about a person's health, diagnose conditions, or monitor treatments.
- Device Function: The description clearly states that this device is a hair removal device that uses pulsed light applied directly to the skin. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is for the removal of unwanted hair and permanent reduction in hair regrowth, which is a cosmetic or aesthetic purpose, not a diagnostic one.
Therefore, based on the provided information, this device falls outside the scope of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Product codes
OHT
Device Description
The Hair Removal Devices (Model:IPL-D26,IPL-D19) are pulsed light hair removal devices. The IPL-D26 and IPL-D19 models use the same components and have the same features except for their color. The IPL-D26 is white and IPLD19 is red. The device uses light pulses to produce hair removal, and the effect of the device is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The IPL-D26 and IPL-D19 devices are each composed of a hand held applicator and an external power supply. Each applicator contains a xenon lamp, a skin color sensor and a skin proximity sensor. The xenon lamp emits the pulsed light flashes to produce hair removal. The skin color sensor is to ensure that the light will be emitted only to skin color appropriate for the device. The contact sensor is to ensure that the light pulses will not be emitted unless the applicator in full contact with the skin. The spot size (treatment area) in the Hair Removal Device devices is 3 cm²
Mentions image processing
Optical Measurement
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed light
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The testing for Hair Removal Device included performance, software, electrical safety, EMC, biocompatibility and bench. Hair Removal Device passed all testing in support of the substantial equivalence determination:
Biocompatibility testing: The biocompatibility evaluation for the Hair Removal Devicewas conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." As dictated by the application of contact with the intact skin, the enclosure of testing included the following tests: Cytotoxicity, Sensitization, Irritation.
Electrical safety and electromagnetic compatibility: Electrical safety, performance and EMC testing were conducted on the Hair Removal Device. The device with compliance with the IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57,IEC 60601-2-83 and IEC 62471 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
Usability: Usability testing has been performed to, and passed, the following standards: IEC 60601-1-6 Medical electrical equipment –Part 1-6: General requirements for safety – Collateral standard: Usability.
Key Metrics
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 21, 2022
Shenzhen Desida Technology Co., Ltd. % Amos Zou RA Engineer Shenzhen CT Bio-Tech Co., Ltd. Room 408, Comprehensive Building, Building 6, Xusheng Building, Xixiang Street, Baoan District Shenzhen, Guangdong 518102 China
Re: K221643
Trade/Device Name: Hair Removal Device (Model: IPL-D26, IPL-D19) 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 30, 2022 Received: June 6, 2022
Dear Amos Zou:
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,
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
2
Indications for Use
510(k) Number (if known) K221643
Device Name Hair Removal Device (Model:IPL-D26,IPL-D19)
Indications for Use (Describe)
The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by section 21 CFR 807.92
1. Submitter of 510(K):
Sponsor:
| Company Name: | Shenzhen Desida Technology Co., Ltd. |
|---|---|
| Address: | 5F, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan |
| Street, Baoan District, Shenzhen City, Guangdong Province, China. | |
| Contact person: | Mr.Gong Yong |
| TEL: | +86-755-28227189/13689585641 |
| FAX: | +86 -755-28227189 |
| E-mail: | 184056776@qq.com |
| 40888122@qq.com | |
| Date of Prepared: | May 30,2022 |
Application Correspondent:
| Company Name: | Shenzhen CT Bio-Tech co., Ltd |
|---|---|
| Address: | Room 408,Comprehensive Building,Building 6,Xusheng Building,Xixiang |
| street,Baoan District,Shenzhen,,Guangdong.518126,China | |
| Contact person: | Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | amos.zou@139.com |
| Date of Prepared: | May 30, 2022 |
2. Proposed Device and code:
| Device Trade Name: | Hair Removal Device(Model:IPL-D26,IPL-D19) |
|---|---|
| Regulation Medical Specialty: | General & Plastic Surgery |
| Product Code: | OHT |
4
Version:1.0
| Device classification Name: | Light Based Over-The-Counter Hair Removal |
|---|---|
| Regulation number | 21 CFR 878.4810 |
| Regulation Description | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology. | |
| Device Class | II |
| Sterilization facility | Not applicable |
| Type: | Traditional |
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K160968 | Ipulse Smoothskin Gold Hair Removal Device | Cyden Limited |
Description of Proposed Device: 4.
The Hair Removal Devices (Model:IPL-D26,IPL-D19) are pulsed light hair removal devices. The IPL-D26 and IPL-D19 models use the same components and have the same features except for their color. The IPL-D26 is white and IPLD19 is red. The device uses light pulses to produce hair removal, and the effect of the device is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The IPL-D26 and IPL-D19 devices are each composed of a hand held applicator and an external power supply. Each applicator contains a xenon lamp, a skin color sensor and a skin proximity sensor. The xenon lamp emits the pulsed light flashes to produce hair removal. The skin color sensor is to ensure that the light will be emitted only to skin color appropriate for the device. The contact sensor is to ensure that the light pulses will not be emitted unless the applicator in full contact with the skin. The spot size (treatment area) in the Hair Removal Device devices is 3 cm²
5. Indications for Use
The Hair Removal Devices (models IPL-D26 and IPL-D19) are over the counter devices intended for the removal of unwanted hair. The devices are intended for permanent reduction in hair regrowth, defined as a long -term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
6. Device Comparison Table
The following table compares the device to the predicate device with basic technological characteristics.
| Subject Device 1 | Predicate Device | Remark | |
|---|---|---|---|
| 510(k) Number | K221643 | K160968 | -- |
| Device Name and | |||
| Model | Hair Removal Device | ||
| (Model:IPL-D26,IPL-D19) | Ipulse Smoothskin Gold Hair | ||
| Removal Device | -- | ||
| Manufacturer | Shenzhen Desida Technology Co., Ltd. | Cyden Limited | -- |
| Enerty Medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | same |
| Wavelength | |||
| Range | 500nm-1200nm | 510-1100nm | Similar |
| Pulse Duration | 2-4 milliseconds | 2ms to 10ms | Similar |
| Energy Density | 1.8-4.9 J/cm² | 3-6J/cm² | Similar |
| Treatment | |||
| window | 3cm² (3cm by 1cm) | 3cm² (3cm by 1cm) | Same |
5
Version:1.0
| Delivery Device
Pulsing Control | Direct Illumination to Tissue
Finger switch | Direct Illumination to Tissue
Finger switch | Same
Same |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Skin Tone Sensor | Optical Measurement
Integral to device.
Continuous measurement. | Optical Measurement
Integral to device.
Continuous measurement. | Same |
| Indications for
Use | The Hair Removal Devices (models
IPL-D26 and IPL-D19) are over the
counter devices intended for the
removal of unwanted hair. The devices
are intended for permanent reduction in
hair regrowth, defined as a long-term,
stable reduction in the number of hairs
re-growing when measured at 6, 9, and
12 months after the completion of
treatment regimen. | The iPulse SmoothSkin Gold Hair
Removal System is indicated for the
removal of unwanted hair. The iPulse
SmoothSkin Gold 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. | Same |
| Use Environment | Over-the-counter | Over-the-counter | Same |
7. PERFORMANCE DATA
The testing for Hair Removal Device included performance, software, electrical safety, EMC, biocompatibility and bench. Hair Removal Device passed all testing in support of the substantial equivalence determination:
7.1. Biocompatibility testing
The biocompatibility evaluation for the Hair Removal Devicewas conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." As dictated by the application of contact with the intact skin, the enclosure of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
7.2. Electrical safety and electromagnetic compatibility
Electrical safety, performance and EMC testing were conducted on the Hair Removal Device. The device with compliance with the IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57,IEC 60601-2-83 and IEC 62471 standards for safety and the IEC 60601-1-2 standard for EMC.
7.3. Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
7.4 Usability
Usability testing has been performed to, and passed, the following standards:
● IEC 60601-1-6 Medical electrical equipment –Part 1-6: General requirements for safety – Collateral standard: Usability
8. Conclusions:
The proposed IPL Hair Removal Device models IPL-D26 and IPL-D19 in this 510(k) use the same IPL technology that is used in the K160968 predicate device and the proposed device models are for the same intended use as the predicate device. Differences between the proposed device models and predicate device do not raise new types of questions regarding safety and effectiveness, and performance testing supports that
6
Version:1.0
the proposed device can be used safely and effectively for the proposed indications for use. The proposed IPL Hair Removal Device models IPL-D26 and IPL-D19 are considered to be substantially equivalent to the K160968 predicate device.