(190 days)
Not Found
No
The summary describes a standard IPL hair removal device and does not mention any AI or ML components, algorithms, or related performance metrics.
No
The device is indicated for hair removal and permanent reduction in hair regrowth, which are cosmetic procedures, not medical therapies.
No
The document explicitly states the device is for hair removal and hair regrowth reduction, not for diagnosing any medical condition.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL)" device that "emits a specific wavelength of the light" and "delivers to the skin," indicating it is a hardware device that produces light energy.
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 for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal Device works by applying light directly to the skin to affect hair follicles. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for hair removal and reduction, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The provided information clearly describes a device that interacts with the body externally for a non-diagnostic purpose.
N/A
Intended Use / 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."
Product codes
OHT
Device Description
"IPL Hair Removal Device (Models:YT01, YT02, YT04) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL)to emit a specific wavelength of the light ranging from 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. 550 filter is applied in models YT01&YT02, 600 filter is applied in model YT03 and 640 filter is applied in model YT04."
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
Not Found
Intended User / Care Setting
"over-the-counter, home-use and single-person-use device"
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
"In order to verify and assure the performance, function and quality of the IPL Hair Removal Device, we have conducted the verification of output energy density, pulse duration time, valid times of flashes.
Meanwhile, in order to ensure the laypersons can choose and use the IPL Hair Removal Device, the human factors engineering verification have been prepared and performed.
To ensure the eye safety of patients and the users, the luminous transmittance of goggles has been tested."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
July 10, 2024
Shenzhen Jianrong Biomedical Electronics Co., Ltd % Yvonne Liu Registration Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518100 China
Re: K240016
Trade/Device Name: IPL Hair Removal Device (YT01,YT02,YT03,YT04) 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: December 21, 2023 Received: January 2, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
for
Yan Fu -S
Digitally signed by Yan Fu -S
Date: 2024.07.10 13:03:13
-04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
IPL Hair Removal Device (YT01, YT02, YT02, YT03,YT04)
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)
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."
4
| 510(k) #: K240016 | 510(k) Summary | Prepared on: 2024-07-10 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Shenzhen Jianrong Biomedical Electronics Co.,Ltd | |||
| Applicant Address | Floor 4, Building 3, Haoer Jiashitai Industrial Park, No.164, Fengtang | |||
| Avenue, Zhancheng Community, Fuhai Street, Bao'an District Shenzhen | ||||
| Guangdong 518103 China | ||||
| Applicant Contact Telephone | 86-19928767549 | |||
| Applicant Contact | Mr. Bruce Liu | |||
| Applicant Contact Email | jianrongyiliao@163.com | |||
| Correspondent Name | Feiying Drug & Medical Consulting Technical Service Group | |||
| Correspondent Address | Rm 2401 Zhenye International Business Center, No. 3101-90, | |||
| Qianhai Road Shenzhen Guangdong 518100 China | ||||
| Correspondent Contact Telephone | 86-17780639776 | |||
| Correspondent Contact | Ms. Yvonne Liu | |||
| Correspondent Contact Email | 251422516@qq.com | |||
| Device Name | ||||
| 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | IPL Hair Removal Device (YT01, YT02, YT03,YT04) | |||
| Common Name | Laser surgical instrument for use in general and plastic surgery and in | |||
| dermatology | ||||
| Classification Name | Light Based Over-The-Counter Hair Removal | |||
| Regulation Number | 878.4810 | |||
| Product Code(s) | OHT | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K221002 | IPL Hair Removal Device | OHT | ||
| K231717 | IPL Home Use Hair Removal Device | OHT | ||
| K222537 | IPL Hair Removal Device | OHT | ||
| Device Description Summary | 21 CFR 807.92(a)(4) |
IPL Hair Removal Device is indicated for the removal of unicicaed for the permanent reduction in hair
regrowth, defined as the long-term, stable reduction in the neasured at
5
completion of a treatment regime.
IPL Hair Removal Device (Models:YT01, YT02, YT04) is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL)to emit a specific wavelength of the light ranging from 550-1200nm and delivers to the skin. The device is designed to help break the cycle of hair re-growth. 550 filter is applied in models YT01&YT02, 600 filter is applied in model YT03 and 640 filter is applied in model YT04.
Intended Use/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.
Indications for Use Comparison
The subject device and predicate devices have the same indications for use.
Technological Comparison
The technical characteristic of IPL Hair Removal Device (YT01, YT02, YT04) are substantially equivalent to the predicate devices in the following aspects:
-
the same intended use, mode of action;
-
the same source energy and power supply: supplied by external adapter with 100-240V~, 50/60Hz;
-
the same light source: Intense Pulsed Light;
-
the same energy medium: Xenon Arc Flashlamp;
-
the same wavelength: 550-1200nm.
The difference between the subject device and the predicate devices mainly includes the following:
-
different spot size: the spot size of the subject device is 4.5cm² while that of the primary predicate device is 3.3cm². The spot size is related to light intensity and since the difference in light intensity is not significant , so this difference will not raise any safety or effectiveness issue.
-
different energy density: the energy density of the subject device is 1.2-4.3J/cm² while that of the primary predicate device is 3.03-5.3 J/cm². The energy density of subject device is similar to the predicate device, and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
Thus the subject device is determined to be substantially equivalent to the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
In order to verify and assure the performance, function and quality of the IPL Hair Removal Device, we have conducted the verification of output energy density, pulse duration time, valid times of flashes.
Meanwhile, in order to ensure the laypersons can choose and use the IPL Hair Removal Device, the human factors engineering verification have been prepared and performed.
To ensure the eye safety of patients and the users, the luminous transmittance of goggles has been tested.
Not applicable. There's no clinical data for the subject device.
The IPL Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Performance data supports that the device is safe and as effective as the predicate device for its intended use.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)