(172 days)
No
The document describes a simple IPL device with a skin sensor and manual activation. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
No.
The device is intended for cosmetic hair removal and reduction, not for treating a disease or condition.
No
The device is described as an IPL hair removal device intended for the reduction of unwanted hair, not for diagnosing any medical condition.
No
The device description clearly states it is a personal, light-based, hair reduction device using Intense Pulsed Light (IPL) technology, powered by an external adapter, and containing a Xenon lamp and skin sensor. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The IPL HAIR REMOVAL (Model: SG-8025) is a light-based device that works on the skin's surface to reduce hair growth. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is for hair removal and permanent hair reduction, which is a cosmetic or aesthetic purpose, not a diagnostic one.
Therefore, the device described is a therapeutic or aesthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IPL HAIR REMOVAL (Model: SG-8025) 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.
Product codes
OHT
Device Description
The IPL HAIR REMOVAL SG-8025 is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and it's IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. 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 device is for single-person use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Adults
Intended User / Care Setting
Over-the-counter directly to the end user.
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)
Non-Clinical Performance Data:
- Biocompatibility Testing: Evaluated according to ISO 10993-1, ISO 10993-5:2009/(R)2014, and ISO 10993-10:2010/(R)2014. Tests performed and passed included In Vitro Cytotoxicity, Irritation, and Skin Sensitization.
- Electrical Safety: Testing performed and passed against IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-57.
- Eye Safety: Testing performed against IEC 62471 Photobiological safety of lamps and lamp systems and ISO 14971 Medical Devices Applications of Risk Management to Medical Devices.
- Software Verification and Validation: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Key results: Based on the performance data, IPL HAIR REMOVAL SG-8025 was found to have a safety and effectiveness profile similar to the predicate devices.
Clinical Performance Data: No clinical tests were performed on the subject device.
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.
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January 14, 2022
Dongguan Define Beauty Electronic Technology Co. Ltd % Helen Nan General Manager Cytech (Shenzhen) Enterprise Management Consulting Co.,Ltd. Room B204, Building 12 Hourui 2nd Industrial Zone, Bao'an District Shezhen, Guangdong 518128 China
Re: K212318
Trade/Device Name: IPL Hair Removal SG-8025 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 7, 2021 Received: December 14, 2021
Dear Helen Nan:
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212318
Device Name IPL HAIR REMOVAL SG-8025
Indications for Use (Describe)
The IPL HAIR REMOVAL (Model: SG-8025) 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Research Use Only (21 CFR 820.30) Subject to Design Controls | For In-Vitro Use Only (21 CFR 820.30) Subject to Design Controls |
|---|---|
| --------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains a logo with the words "Define beauty" written in a cursive font. Above the English text, there are three Chinese characters in a stylized, calligraphic style. The overall design has a flowing, elegant feel, with the text and characters interconnected by curved lines.
Ongguan Define Beauty Electronic Technology Co. Ltd
510(k) Summary K212318 (As required by 21 CFR 807.92(a))
1.0 Submitter Information
| Company: | Dongguan Define Beauty Electronic Technology
Co. Ltd. |
|--------------------------|--------------------------------------------------------------------------------------------------|
| Address | No.10 Xiangya Road, Jichiling Village,
Dalingshan Town, Dongguan, Guangdong,
523812, CHINA |
| Phone: | 0086-0769-89367468 |
| Contact | Shaowu Wang |
| Title: | General Manager |
| • Date: January 13, 2022 | |
2.0 Device Information
| Trade/Device Name: | IPL HAIR REMOVAL SG-8025 |
|---|---|
| Model: | SG-8025 |
| Common Name: | IPL Hair Removal Device |
| Device: | Light Based Over-The-Counter Hair Removal |
| Definition: | Over-the-counter device uses thermal energy to |
| kill hair follicles for hair removal. | |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OHT |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | CFR 878.4810 |
| Device Class: | Class II |
3.0 Predicate Device Information
| Trade/Device Name: | IPL Salon Hair Reduction System |
|---|---|
| 510k Number: | K181568 |
| Submitter: | Medical Device Branch of Zhangzhou Easepal Industrial Co.,Ltd. |
4.0 Device Description
The IPL HAIR REMOVAL SG-8025 is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and it's IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. 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 device is for single-person use only.
4
Image /page/4/Picture/0 description: The image contains a logo for a beauty company. The logo is pink and features the words "Define beauty" in a cursive font. Above the text is a Chinese character in a similar pink color. The logo is simple and elegant, and it conveys a sense of beauty and sophistication.
东莞市定义美电子科技有限公 Dongguan Define Beauty Electronic Technology Co. Ltd
5.0 Indications for Use
The IPL HAIR REMOVAL (Model: SG-8025) 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.
| 6.0 Comparison of Technological Characteristics with the Predicate Device |
|---|
| Table |
| Device Feature | Predicate Device | Subject Device |
|---|---|---|
| Trade Name | IPL Salon Hair Reduction System | IPL HAIR REMOVAL |
| SG-8025 | ||
| 510k number | K181568 | K212318 |
| Classification Name | Light Based Over-The-Counter Hair Removal | |
| Regulation Number | CFR 878.4810 | |
| Product code | OHT | |
| Use | OTC use | |
| Indication for use | 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 IPL Hair Removal (Model: SG-8025) 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. |
| Device Type | Intense Pulsed Light | Intense Pulsed Light |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue |
| Device Design | ||
| Source Energy | Supplied by external adapter | Supplied by external adapter |
| Wavelength range | 475-1200 nm | 530 nm |
| Spot size | Regular window: 4.5cm² | |
| Facial adapter: 1.72cm² | 3 cm² | |
| Pulse duration | 11-12 ms | 1ms |
| Pulse control | Finger switch | Finger switch |
| Weight | 650g | 220g |
| Output Intensity | ||
| Level | 5 level | 5 level |
| Max Energy | ||
| density | Up to 5 J/cm² | 2.5 J/cm² |
| Output energy | ||
| with facial | ||
| adapter | Level 1: 8.62J | |
| Level 2: 9.45J | ||
| Level 3: 10.64J | ||
| Level 4: 11.48J | ||
| Level 5: 12.70J | Level 1: 7.5J | |
| Level 2: 8.5J | ||
| Level 3: 9.5J | ||
| Level 4: 11J | ||
| Level 5: 12J | ||
| Dimensions | 14369.543mm(HWD) | 2057656mm(HWD) |
| Software/Firmwar | ||
| e/Microprocessor | ||
| Control? | Yes | Yes |
| Standards | ||
| 60601 Compliance | ||
| 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 | ||
| Biocompatibility | All user directly contacting | |
| materials are compliance | ||
| with ISO10993-5 and | ||
| ISO10993-10 requirements. | All user directly contacting | |
| materials are compliance | ||
| with ISO10993-5 and | ||
| ISO10993-10 requirements. | ||
| Electrical Safety | Comply with IEC60601-1 | |
| and IEC60601-2-57 | Comply with IEC60601-1 | |
| and IEC60601-2-57 |
Table 1 - Device Comparison Table
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Image /page/5/Picture/0 description: The image contains a logo with the words "Define beauty" written in a cursive font. Above the English text, there are three Chinese characters in a stylized, calligraphic style. The logo is primarily pink or red, with the text and characters sharing the same color scheme. A decorative flourish underlines the text, adding to the overall aesthetic appeal of the logo.
市定义美甲子科技有限公
Dongguan Define Beauty Electronic Technology Co. Ltd
A brief summary of the similarities and differences between IPL Salon Hair Reduction System and IPL HAIR REMOVAL SG-8025 is included below:
Similarities:
The IPL Home Use Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the IPL HAIR REMOVAL may be found substantially equivalent to its predicate device.
Differences:
Basic Characteristics
"Weight", "Dimensions" is belong to basic characteristics. Although it is a little different from the predicate device, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.
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Image /page/6/Picture/0 description: The image contains a logo with the words "Define beauty" written in a cursive font. Above the English text, there are three Chinese characters in a stylized, calligraphic style. The logo is primarily pink or red in color, with the Chinese characters appearing bolder and more prominent than the English text. The overall design has a feminine and elegant aesthetic.
ongguan Define Beauty Electronic Technology Co. Ltd
Max Energy Density
Although the Max. Fluence of subject device is a little less than the the Predicate device, but they all comply with IEC 60601-1, IEC 60601-2-57 requirement. So the differences of function specification will not raise any safety or effectiveness issue.
Pulse Duration
Although the Pulse Duration of subject device is less than the predicate device, the subject device comply with all electrical safety eye safety and EMC Standard, So the differences of pulse duration time will not raise any safety or effectiveness issue.
Wavelength
Although the wavelength of subject device is a little different from the predicate devices, but they all comply with IEC 60601-1, IEC 60601-2-57 requirement. And the wavelength of subject device is in the range of the one of predicted device. So the differences of function specification will not raise any safety or effectiveness issue.
Spot Size
There is minor difference in Spot size between the subject device and the predicate devices. And they all comply with IEC 60601-1, IEC60601-2-57 requirement. So the differences of Spot size will not raise any safety or effectiveness issue.
7.0 Non- Clinical Performance Data
The following performance data were provided in support of the substantial equivalence determination.
7.1 Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Remover was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:
- A ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
- A ISO 10993-10:2010/(R)2014, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization
7.2 Electrical Safety
- A Electrical safety and Eye safety testing was performed to, and passed, the following standards:
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Image /page/7/Picture/0 description: The image shows a logo with the words "Define beauty" written in a cursive font. Above the words, there are three Chinese characters in a stylized font. The logo is pink and has a decorative flourish above and below the text.
义美电子科技有限公
Dongguan Define Beauty Electronic Technology Co. Ltd
-
60601-1-2 Medical electrical equipment -Part 1-2: General IEC requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- A IEC 60601-2-57 Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
7.3 Eve Safety
- IEC 62471 Photobiological safety of lamps and lamp systems A
- ISO 14971 Medical Devices Applications of Risk Management to A Medical Devices
7.4 Software Verification and Validation
- Software documentation consistent with moderate level of concern was A submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Based on the above performance as documented in this application, IPL HAIR REMOVAL SG-8025 was found to have a safety and effectiveness profile that is similar to the predicate devices.
8.0 Clinical Performance Data
No clinical tests was performed on the subject device.
9.0 Conclusion:
IPL HAIR REMOVAL SG-8025 was found to be substantially equivalent to the predicate devices and shares the same or similar indications for use, design, operational and functional features as the predicate devices. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.