(80 days)
Not Found
No
The summary describes a light-based hair removal device using IPL technology and a skin proximity sensor. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, data analysis, or treatment optimization. The device operates based on fixed energy levels and a simple contact sensor.
No
The device is described as being for "patient removal of unwanted hair" and "permanent reduction in unwanted hair," which are cosmetic rather than therapeutic purposes.
No
The device is intended for patient removal of unwanted hair and permanent reduction in unwanted hair, which are therapeutic and cosmetic purposes, not diagnostic ones.
No
The device description explicitly states it is a "light-based device" and a "hand-held device consists of main unit and adaptor," using "IPL technology" and a "Xenon Lamp" to emit light. These are hardware components, not software.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Aimanfun Lumea Comfort is a light-based device for hair removal. It works by applying light energy to the skin to target hair follicles.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. It directly interacts with the skin surface.
- Intended Use: The intended use is for hair removal and permanent hair reduction, not for diagnosing or monitoring any medical condition through the analysis of biological samples.
Therefore, the Aimanfun Lumea Comfort falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aimanfun Lumea Comfort (Model: A-2789, A-3588) 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 months after the completion of a treatment regimen.
Product codes
ONF
Device Description
Aimanfun Lumea Comfort is a light-based device for long-term hair removal, designed for home environment used. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment.
The device uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity 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 be triggered a pulse emitting.
The device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarms, bikini line, arms and legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.
home environment used.
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)
As the modifications of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device are suitable for use in the assessment of the subject device. So this submission leverages performance and electrical testing provided in previous submissions.
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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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 & 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.
December 2, 2021
Kam Yuen Plastic Products Ltd. % Jett Lee Regulation manager Guangdong Jianda Medical Technology Co Ltd 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong China
Re: K212907
Trade/Device Name: Aimanfun Lumea Comfort, A-2789/A-3588 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: ONF Dated: October 29, 2021 Received: November 3, 2021
Dear Jet Lee:
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212907
Device Name Aimanfun Lumea Comfort , Model: A-2789, A-3588
Indications for Use (Describe)
The Aimanfun Lumea Comfort (Model: A-2789, A-3588) 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 months after the completion of a treatment regimen.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1 Submitter Information
Sponsor: Kam Yuen Plastic Products Ltd. Establishment Registration Number: 10078856 Address: No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town, ZhongShan, Guangdong, China Phone: 86- 400- 962- 1668 Fax: 86-0760- 8841- 3080 Contact Person: Anna Dan E-mail: kamyuen@kyplastic.com
Application Correspondent: Jett Lee Company: Guangdong Jianda Medical Technology Co., Ltd E-mail: jianda-lee@foxmail.com Phone: 86-13512755282 Address: 906 Room, Longxiang Garden, Tianhe district, Guangzhou, China
Subject Device Information 2
Type of 510(k) submission: Special 510(k): Device Modification Common Name: Light based hair removal devices Trade Name: Aimanfun Lumea Comfort Model: A-2789, A-3588 Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Regulation Number: 21 CFR 878.4810 Regulation Class: 2
3 Leqally marketed device (predicate device) Information
Common Name: Light based hair removal devices Trade Name: Aimanfun Lumea Comfort Model: A-2788 510K Number: K190820 Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Regulation Number: 21 CFR 878.4810
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Regulation Class: 2
4 Device Description
Aimanfun Lumea Comfort is a light-based device for long-term hair removal, designed for home environment used. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment.
The device uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity 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 be triggered a pulse emitting.
The device is a home-use and hand-held device consists of main unit and adaptor, for the permanent reduction of hair growth based on Intense Pulsed Light (IPL).
5 Intended Use
The Aimanfun Lumea Comfort (Model: A-2789, A-3588) 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 months after the completion of a treatment regimen.
6 Complied Standards
Aimanfun Lumea Comfort (Model: A-2789, A-3588) complies with the following FDA recognized consensus standards:
- മ IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2012 +A1:2012
- 区 IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
- 网 IEC 60601-1-11:2015 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
- 区 IEC 60601-2-57:2011 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 cos metic/aesthetic use
- ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: ಷ
5
Tests For In Vitro Cytotoxicity
- 网 ISO 10993-10:2010, Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization
- Guidance for the Content of Premarket Submissions for Software Contained in 区 Medical Devices
7 Device modification description
All the modifications of subject device are shown in the following table as below, and no other changes were made to legally existing predicate device.
| Design
| modification | Before modification | After modification | |
|---|---|---|---|
| Model name | A-2788 | A-2789 | A-3588 |
| Appearance | Image: A-2788 | Image: A-2789 | Image: A-3588 |
| Structure and | |||
| Buttons | Skin Contact Window | ||
| Integrated UV filter | |||
| Energy Level Indicator | |||
| Ready Lamp | |||
| Power Adapter | Skin Contact Window | ||
| Integrated UV filter | |||
| LCD Screen | |||
| Power Adapter | Skin Contact Window | ||
| Integrated UV filter | |||
| LCD Screen | |||
| Power Adapter | |||
| Indicator Light | |||
| 5-level Button | |||
| Flash Key | ON/OFF Button | ||
| Flash Key | ON/OFF Button | ||
| ICE Button | |||
| Flash Key | |||
| Work mode | Single flash mode | Single flash mode | |
| Sliding flash mode | Single flash mode | ||
| Sliding flash mode | |||
| Ice-sensing | |||
| function | No | No | Yes |
| Dimensions | |||
| WDH | 82x138.9x47.3(mm) | 82x138.9x47.5(mm) | 74x135x233(mm) |
| Weight | 200g | 241g | 360g |
8 Performance Testing
As the modifications of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device are suitable for use in the assessment of the subject device. So this submission leverages performance and electrical testing provided in previous submissions.
9 Biocompatibility
All the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing. This
6
submission leverages biocompatibility test report provided in previous submissions.
10 Clinical performance
Clinical performance is not deemed necessary.
11 Comparison with predicate device
Compare with predicate device, the subject device is very similar in design principle, intended use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Manufacturer | Kam Yuen Plastic Products Ltd | Kam Yuen Plastic Products Ltd | -- | |
| Product Name | Aimanfun Lumea Comfort | Aimanfun Lumea Comfort | -- | |
| Model | A-2789 | A-3588 | A-2788 | -- |
| 510(K) No. | TBD | K190820 | -- | |
| Indications for | ||||
| Use | The Aimanfun Lumea Comfort (Model: A-2789, | |||
| A-3588) 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 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 months | ||||
| after the completion of a treatment | ||||
| regimen. | SE | |||
| IFU Type | Prescription use | Prescription use | Prescription use | SE |
| Classification | OHT/ONF | OHT/ONF | OHT/ONF | SE |
| Technology | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | SE |
| Device Design | ||||
| Device Type | Hand-held | Hand-held | Hand-held | SE |
| Status display | LCD screen | LCD screen | LED indicators | SE |
| Note 1 | ||||
| Work mode | Single flash mode | |||
| Sliding flash mode | Single flash mode | |||
| Sliding flash mode | Single flash mode | SE | ||
| Note 2 | ||||
| Ice-sensing | ||||
| function | No | Yes | No | SE |
| Note 3 | ||||
| Power source | External power supply | External power supply | External power supply | SE |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Verdict | |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE | |
| Wavelength | 475~1200nm | 475~1200nm | SE | |
| Spot Size | 3.0 cm2 | 3.0 cm2 | SE | |
| Max. Fluence | 4.5 J/cm² | 4.5 J/cm² | SE | |
| Pulse duration | 3 milliseconds | 3 milliseconds | SE | |
| Output energy | 7-13.5 J | 7-13.5 J | SE | |
| Pulsing Control | Finger switch | Finger switch | SE | |
| Delivery Device | Direct Illumination to Tissue | Direct Illumination to Tissue | SE | |
| Software | ||||
| Control | Yes | Yes | SE | |
| FDA-Recognized Standards | ||||
| IEC 60601-1 | IEC 60601-1 | |||
| Electrical | IEC 60601-1-2 | IEC 60601-1-2 | ||
| safety, EMC, | ||||
| Biological | ||||
| Evaluation | IEC 60601-1-11 | IEC 60601-1-11 | SE | |
| IEC 60601-2-57 | IEC 60601-2-57 | |||
| ISO 10993-5 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-10 |
7
Note 1
Although the subject device utilizes a LCD screen instead of indicator lamps to display device status, such as Device On/Off, Output Energy Level, Flash Ready/Recharging and Lamp lifetime, those do not result in a change in functionality and technical specification. So the difference does not affect the safety and effectiveness.
Note 2
Although the subject device provides extra sliding flash mode, which is only to trigger IPL flash continuously, instead of manually trigger under single flash mode. The difference does not result in a change of IPL technical specifications, so the difference does not affect the safety and effectiveness.
Note 3
Although the subject device (model: A-3588) provides an ice-sensing function, which utilizes a thermoelectric cooler under the skin contact window, the function is only to make patients comfortable with slightly cool sensation after IPL treatment, and have no therapeutic effect. The difference does not result in a change of IPL technical specifications, so the difference does not affect the safety and effectiveness.
Conclusion
The subject device has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate device.