(184 days)
Not Found
No
The summary describes a light-based hair removal device utilizing IPL technology and a skin proximity sensor. There is no mention of AI, ML, or any software features that would suggest the use of such technologies for image processing, decision-making, or adaptive treatment. The performance studies listed are standard electrical and biological safety tests, not AI/ML performance evaluations.
Yes
The device is indicated for "patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician," and for "permanent reduction in unwanted hair," which points to a therapeutic purpose.
No
The device is an IPL hair removal system, designed for therapeutic or cosmetic purposes (hair reduction), not for diagnosing medical conditions.
No
The device description clearly states it is a light-based device incorporating hardware components like a Xenon Lamp and a skin proximity sensor, and its size is provided, indicating a physical device.
Based on the provided information, the Aimanfun Lumea Comfort (Model: A-2788) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Aimanfun Lumea Comfort is a light-based device used directly on the skin for hair removal.
- The intended use and device description clearly state its purpose is for hair removal and permanent hair reduction. This is a physical treatment applied to the body, not a diagnostic test performed on a sample.
- There is no mention of analyzing biological specimens or providing diagnostic information.
Therefore, the Aimanfun Lumea Comfort is a therapeutic device, specifically a light-based hair removal system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. 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 size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal 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
underarms, bikini line, arms and legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, healthcare professional
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)
Aimanfun Lumea Comfort, Model: A-2788 has been evaluated the safety and performance by lab bench testing as following:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2012 +A1:2012
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
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
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.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
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.
K160968, K161428, K172791, K 132170
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 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.
October 2, 2019
Kam Yuen Plastic Products Ltd % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F. No.1 TianTai road, Science City, LuoGang District Guangzhou, Cn
Re: K190820
Trade/Device Name: Aimanfun Lumea Comfort 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: March 24, 2019 Received: April 1, 2019
Dear Jet Li:
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 Acting 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
2
Indications for Use
510(k) Number (if known) K190820
Device Name
The Aimanfun Lumea Comfort (Model: A-2788)
Indications for Use (Describe)
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.
| 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
K190820 510(k) Summary
Date of the summary prepared: October 2, 2019
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor
- � 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:
- Company: Guangzhou KEDA Biological Tech Co., Ltd. �
- Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China �
- � Contact Person: Mr. Jet Li
- � Tile: Regulation Manager
- � Tel: +86-18588874857
- � Email: med-jl@foxmail.com
2. Subject Device Information
- � Trade Name: Aimanfun Lumea Comfort, Model: A-2788
- Light based hair removal devices � Common Name:
- Powered Light Based Non-Laser Surgical Instrument With Classification name: �
- Thermal Effect
- General & Plastic Surgery � Review Panel:
- ONF � Product Code:
- 2 � Regulation Class:
4
878.4810 � Regulation Number:
3. Predicate Device Information
Predicate device I - IV:
| Sponsor | CyDen Limited | Shen Zhen
CosBeauty
Co., Ltd | Conair
Corporati
on | Shaser,
Inc. |
|-------------------|--------------------------------------------------|------------------------------------|----------------------------------|----------------------|
| Device Name | iPulse SmoothSkin
Gold Hair Removal
System | Perfectsmo
oth | Lumilisse
IPL Hair
Remover | Shaser V-
MINI RX |
| 510(k) Number | K160968 | K161428 | K172791 | K 132170 |
| Product Code | OHT | OHT | OHT | ONF |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | Class II | Class II | Class II | Class II |
4. Device Description
Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. 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 size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal 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 / Indications for Use
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.
5
| Sponsor: | Kam Yuen Plastic Products Ltd |
|---|---|
| Subject Device: | Aimanfun Lumea Comfort, Model: A-2788 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
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. Design
Hand-held IPL device (Aimanfun Lumea Comfort) consists of main unit and adaptor. It is a portable device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL) which is a xenon lamp.
The size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse
Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the
IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
7. Materials
There is one part of patient directly contacting component in the subject device as the following list.
| Component of
Device Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Housing of unit | ABS | Surface-contacting
device: skin | Maximum 30
minutes(Specification | |
| Output Intensity Level | 5 steps |
| Output energy | 7-13.5J |
| Emitted Light Spectrum | 475nm~1200nm Max |
| Pulse width range | 3 ms |
| Power Supply | 100-240 VAC, 50/60Hz, 0.5A |
| Technology | IPL |
9. Test Summary
Aimanfun Lumea Comfort, Model: A-2788 has been evaluated the safety and performance by lab bench testing as following:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2012 +A1:2012
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
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
7
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.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
10. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Aimanfun Lumea Comfort, model: A-2788 is substantially equivalent to the predicate devices quoted above. Aimanfun Lumea Comfort relies on the same technology as both predicate devices : Intense Pulsed Light (IPL). Their energy source is the same: Xenon Arc Flashlamp.
The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:
• Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. Aimanfun Lumea Comfort and the predicate devices utilize the same spectrum as the Perfectsmooth predicate device (475-1200nm).
• Fluence/flux - defines the energy per area (e.g. joules per cm²) for the treatment. Aimanfun Lumea Comfort and the predicate devices deliver the same maximum energy (4.5 joules/cm2).
The following technological differences exist between the subject and predicate devices I to III:
- Prescription use for subject device:
- । No Skin tone sensing circuit; but subject device and predicate devices IV is the same design on this feature and both of them are also for prescription use.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
8
| Elements of
Comparison | Subject Device | Primary Predicate
Device I | Predicate Device
II | Predicate Device
Device III | Predicate
Device IV | Verdict |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Manufacturer | Kam Yuen Plastic
Products Ltd | CyDen Limited. | Shen Zhen
CosBeauty Co.,
Ltd | Conair
Corporation | Shaser, Inc. | -- |
| Product Name | Aimanfun Lumea
Comfort, Model: A-
2788 | iPulse SmoothSkin
Gold Hair Removal
System | Perfectsmooth | Lumilisse IPL
Hair Remover | Shaser V-MINI
RX | -- |
| 510(K) No. | Applying | K160968 | K161428 | K172791 | K 132170 | -- |
| Indicationsfor
Use | 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 | 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 | The IPL Hair
Removal Device
Joy Version is an
over-the-counter
device intended for
removal of
unwanted hair
such as but not
limited to small
areas such as
underarm and
facial hair below
the chin line and
large areas such
as legs. | The Lumilisse IPL
(Intense Pulsed
Light) Hair
Remover is an
over-the-counter
device intended
for the removal of
unwanted hair. | The Shaser V-
MINI RN Hair
Removal System
is intended to
provide
phototherapeutic
light to the body
and is generally
indicated to treat
dermatological
conditions. It is
also intended for
removal of
unwanted
hair by using a
selective
photothermal
treatment. The
Shaser V-MINI
RN Hair Removal
System is
indicated for
patient removal of | SE
Note 1 |
| Elements of
Comparison | Subject Device | Primary Predicate
Device I | Predicate Device
II | Predicate
Device III | Predicate
Device IV | Verdict |
| | regrowing when
measured at 6. 9. and
12 months after the
completion of a
treatment regimen. | regrowing when
measured at 6, 9
and 12 months after
the completion of a
treatment regime. | | | unwanted hair by
using a selective
photothermal
treatment under
the direction of a
physician. after
training by a
healthcare
professional. It
is also indicated
for the removal of
unwanted body
and/or facial hair
in adults with
Fitzpatrick skin
types I - VI. The
Shaser V-MINI
RX Hair Removal
System 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 | |
| Elements of
Comparison | Subject Device | Primary Predicate
Device I | Predicate Device
II | Predicate
Device III | Predicate
Device IV | Verdict |
| | | | | | treatment
regimen. | |
| IFU Type | Prescription use | Over-The-Counter | Over-The-Counter | Over-The-
Counter | Prescription use | SE
Note 2 |
| Classification
Product Code | ONF | OHT | OHT | OHT | ONF | SE |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed
Light | | SE |
| | Device Design | | | | | |
| Power source | an external power
supply | AC Mains | an external power
supply | an external power
supply | Battery charger | SE |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | SE |
| Wavelength | 4751200nm | 510nm1100nm | 475nm1200nm | 550-1200 nm | 4001200nm | SE |
| Spot Size | 3.0 cm2 | 3 cm2 | 4.5 cm2 | About 3 cm2 | 2 cm2 | SE |
| Max. Fluence
(J/cm²) | 4.5 J/cm² | 3-6 J/cm² | 4.7 J/cm² | 4.5 J/cm² | 6-10 J/cm² | SE |
| Pulse duration | 3 milliseconds | 2-10 milliseconds | 11-13 milliseconds | - | - | SE |
| Elements of
Comparison | Subject Device | Primary Predicate
Device I | Predicate Device
II | Predicate
Device III | Predicate
Device IV | Verdict |
| | | | | | | Note 3 |
| Output energy | 7-13.5 J | 9-18 J |