(82 days)
No
The description focuses on IPL technology, energy levels, and a skin proximity sensor. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended for the removal or reduction of unwanted hair, which is a cosmetic purpose rather than treating a medical condition or disease.
No
The device is described as an over-the-counter device intended for the removal or reduction of unwanted body and/or facial hair, which is a cosmetic purpose, not a diagnostic one.
No
The device description clearly states it is a "hand-held device" that uses Intense Pulsed Light (IPL) technology with a Xenon Lamp and a skin proximity sensor. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of unwanted body and/or facial hair. This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Mechanism of Action: The device uses Intense Pulsed Light (IPL) to heat hair roots and reduce hair growth. This is a physical interaction with the body, not an in vitro test of a biological sample.
- Definition of IVD: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests.
The information provided clearly describes a device for hair removal, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment.
The hand-held device package includes main unit, adaptor and user manual and it 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair. Ideal body areas include the underarms, bikini line, arms and legs.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
As the modification 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 (legally existing device) are suitable for use in the assessment of the subject devices except for usability study verification. In usability study, the testing result demonstrates that the intended users can understand the package labeling, correctly choose the device and use it for the indicated OTC use, based on reading the lableling materials.
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.
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
April 5, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
Kam Yuen Plastic Products Ltd. % Iris Fung Regulation manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China
Re: K230107
Trade/Device Name: Aimanfun Lumea Comfort, Model: A-2788, A-2789 and 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: OHT Dated: January 13, 2023 Received: January 13, 2023
Dear Iris Fung:
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.
Colin K. C
for
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) K230107
Device Name
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
Indications for Use (Describe)
Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.
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)
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3
510(k) Summary
K230107
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
Company Name: Kam Yuen Plastic Products Ltd.
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 (including title): Anna Dan
E-mail: kamyuen@kyplastic.com
Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd Tel: +86-13512755282 Email: jianda-lee@foxmail.com Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
2 Subject Device Information
Trade Name: Aimanfun Lumea Comfort Model: A-2788, A-2789 and A-3588 Common Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHT Requlation Number: 878.4810
4
Requlation Class: 2
3 Predicate device Information
Legally marketed device K190820
Trade Name: Aimanfun Lumea Comfort
Model: A-2788
Common Name: Light based hair removal devices
Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal
Effect
Review Panel: General & Plastic Surgery
Product Code: ONF
Regulation Number: 878.4810
Regulation Class: 2
Leqally marketed device K212907
Trade Name: Aimanfun Lumea Comfort Model: A-2789, A-3588 Common Name: Light based hair removal devices Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Requlation Number: 878.4810
Regulation Class: 2
Reference device K211185
Common Name: IPL Home Use Hair Removal Device
Model: D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187
Common Name: Light Based Over-The-Counter Hair Removal
5
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 878.4810 Regulation Class: 2
4 Device Description
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment.
The hand-held device package includes main unit, adaptor and user manual and it 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.
5 Intended Use
Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.
6 Complied Standards
Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 complies with the following FDA recognized consensus standards:
- . IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
6
- . 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
- . 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 cosmetic/aesthetic use
- . IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
- 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.
7 Device modification description
The only modification of subject device is Intended Use. The device has changed to overthe-counter use. Therefore, the User Manual and Box labelling has been adding corresponding use instructions for lay person user.
8 Performance Testing
As the modification 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 (legally existing device) are suitable for use in the assessment of the subject devices except for usability study verification. In usability study, the testing result demonstrates that the intended users can understand the package labeling, correctly choose the device and use it for the indicated OTC use, based on reading the lableling materials.
As there have been no changes to the performance of the subject device from the predicate
7
device, this submission leverages performance and electrical testing provided in previous submission.
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. No biocompatibility test report is provided in this submission.
10 Clinical performance
Clinical performance is not deemed necessary.
8
11 Comparison with predicate device
Compare with predicate device (Aimantun Lumea Comfort, K190820 and K212907), the subject device is same in design principle, functions, material and
the applicable standards. The differences between subject devices do not raise any new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| Manufacturer | Kam Yuen Plastic Products Ltd. | Kam Yuen Plastic Products Ltd. | Kam Yuen Plastic Products Ltd. |
| Product Name | Aimanfun Lumea Comfort | Aimanfun Lumea Comfort | Aimanfun Lumea Comfort |
| Model | A-2788, A-2789 and A-3588 | A-2789 | |
| A-3588 | A-2788 | ||
| 510(K) No. | K230107 | K212907 | K190820 |
| Indications for | |||
| Use | Aimanfun Lumea Comfort is an over- | ||
| the-counter device intended for | |||
| removal of unwanted body and/or | |||
| facial hair. | 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. | The Aimanfun Lumea Comfort (Model: A- |
- 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. |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
| | | 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. | 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 | Over-The-Counter Use | Prescription use | Prescription use |
| Classification | OHT | ONF | ONF |
| Product Code | | | |
| Technology | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light |
| Device Type | Hand-held | Hand-held | Hand-held |
| Status display | A-2788: LED indicators | | |
| | A-2789: LCD screen | LCD screen | LED indicators |
| | A-3588: LCD screen | | |
| Work mode | A-2788: Single flash mode | Single flash mode | Single flash mode |
| | A-2789: Single flash mode, Sliding | Sliding flash mode | |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
| | flash mode
A-3588: Single flash mode, Sliding
flash mode | | |
| Ice-sensing
function | A-2788: No
A-2789: No
A-3588: Yes | No | No |
| Power source | External power supply | External power supply | External power supply |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Wavelength | 4751200nm | 4751200nm | 475~1200nm |
| Spot Size | $3.0 cm^2$ | $3.0 cm^2$ | $3.0 cm^2$ |
| Max. Fluence | $4.5 J/cm^2$ | $4.5 J/cm^2$ | $4.5 J/cm^2$ |
| Pulse duration | 3 milliseconds | 3 milliseconds | 3 milliseconds |
| Output energy | 7-13.5 J | 7-13.5 J | 7-13.5 J |
| Pulsing Control | Finger switch | Finger switch | Finger switch |
| Delivery Device | Direct Illumination to Tissue | Direct Illumination to Tissue | Direct Illumination to Tissue |
| | | Yes | |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 |
| Software Control | Yes | Yes | Yes |
| Electrical safety,
EMC, Biological
Evaluation | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 |
| | IEC 60601-2-57 | IEC 60601-2-57 | IEC 60601-2-57 |
| | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 |
| | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 |
9
10
11
12
12 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the subject device Aimanfun Lumea Comfort is to be concluded substantial equivalent to its predicate device.
13 Summary Prepared Date
Apr 04, 2023