(170 days)
Not Found
No
The 510(k) summary describes a standard IPL device with variations in appearance and spot size. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies listed are standard safety and electrical tests, not AI/ML validation.
No
The device is described as an "IPL Beauty Device" intended for "removal of unwanted hair", which is generally considered a cosmetic use rather than a therapeutic one. The primary function is hair reduction, not treating a disease or medical condition.
No
Explanation: The device is intended for hair removal, which is a cosmetic procedure, not a diagnostic one. Diagnostic devices are used to identify the presence or nature of a disease or condition.
No
The device description clearly states it is a "light-based, hair reduction device" using "IPL technology" and includes physical components like a "main body," "power adapter," and a "non-removable lamp head (light-emitting treatment window)" which is the source of optical radiation. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted hair". This is a cosmetic or aesthetic procedure performed directly on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "light-based, hair reduction device" using IPL technology. It applies light energy to the skin.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
IVD devices are specifically designed to perform tests in vitro (outside the living body) on biological specimens to provide information about a person's health status. This device operates in vivo (on the living body) for a cosmetic purpose.
N/A
Intended Use / Indications for Use
The Home Use IPL Beauty Device 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.
Product codes
OHT
Device Description
The Home Use IPL Beauty Device 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 IPL technology. Of which, the Device includes MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6 and MELSYA-M7 six models. All have adopted the same structure design, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.
The difference of all models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of model MS-208B, MS212B and MELSYA-M6 is designed to 3.6cm², model MS-216B, MS-218B and MELSYA-M7 is designed to 3.0 cm2, as well as the energy density of the all models is in the range of 2.0~5.1J/cm².
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underarm, facial hair below the chin line, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
end user / Home Healthcare Environment (OTC)
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
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the subject device 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", as recognized by FDA. The battery of testing was performed to, and passed, including:
- 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
- Electrical Safety and Eye Safety: Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- IEC 60601-1:2005, MOD Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- 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
- Eye Safety:
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
- Software Verification and Validation: Software documentation consistent with moderate level of concern was 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.
Key results: Based on the above performance, the subject device Home Use IPL Beauty Device was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics
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.
July 23, 2021
Shenzhen Mismon Technology Co., Ltd. Rain Yip Registered Engineer 4th Floor, Building B, Zone A, Longquan Technology Park, Tongfuyu Phase2, Tongsheng Community Shenzhen, Guangdong 518000 China
Re: K210311
Trade/Device Name: Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. 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: April 3, 2021 Received: June 21, 2021
Dear Rain Yip:
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210311
Device Name
Home Use IPL Beauty Device Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSY A-M7
Indications for Use (Describe)
The Home Use IPL Beauty Device 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.
| 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
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2021-01-25
I. Submitter
Shenzhen Mismon Technology Co., Ltd. 4th Floor, Building B, Zone A, Longquan Technology Park, Tongfuyu Phase 2, Tongsheng Community, Dalang Street, Longhua District, Shenzhen, China 518000 Tel.: +86 755 23732187
Vicky Yang General Manager Tel: +86 158 1871 5190 Email: vicky@mismon.com
II. Device
Name of Device: Home Use IPL Beauty Device Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7 Common or Usual Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Device
The predicate devices are listed as below:
-
- Primary: K180016, Home Use IPL Beauty Device/MELSYA-MA, MS-206B, manufactured by Shenzhen Mismon Technology Co., Ltd., and cleared March 20, 2018
-
- K192432, IPL Home Use Hair Removal Device/D-1128, manufactured by Shenzhen Bosidin Technology Co., Ltd., and cleared November 11, 2019
IV. Device Description
The Home Use IPL Beauty Device 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 IPL technology. Of which, the Device includes MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6 and MELSYA-M7 six models. All have adopted the same structure design, consisting of IPL beauty device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of
4
optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.
The difference of all models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of model MS-208B, MS212B and MELSYA-M6 is designed to 3.6cm², model MS-216B, MS-218B and MELSYA-M7 is designed to 3.0 cm2, as well as the energy density of the all models is in the range of 2.0~5.1J/cm².
V. Indications for Use
The Home Use IPL Beauty Device 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.
VI. Comparison of Technological Characteristics With the Predicate Device
The Home Use IPL Beauty Device has the same intended use, mode of action and similar operational characteristics as the predicate device. 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 Home Use IPL Beauty Device may be found substantially equivalent to its predicate device.
Home Use IPL Beauty Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
-
- (Primary) K180016, "Home Use IPL Beauty Device/MELSYA-MA, MS-206B", manufactured by "Shenzhen Mismon Technology Co., Ltd." in Guangdong, China
-
- K192432, "IPL Home Use Hair Removal Device/D-1128", manufactured by "Shenzhen Bosidin Technology Co.,Ltd" in Guangdong, China
| Comparison
Elements | Subject Device | Predicate Device 1
(Primary) | Predicate Device 2 |
|------------------------|-----------------------------------------------|-----------------------------------------------------|--------------------------------------------------|
| K Number | Pending | K180016 | K192432 |
| Common name | Light Based Over-The-
Counter Hair Removal | Light Based Over-The-
Counter Hair Removal | Light Based Over-
The-Counter Hair
Removal |
| Trade name | Home Use IPL Beauty
Device | Home Use IPL Beauty
Device/MELSYA-MA,
MS-206B | IPL Home Use Hair
Removal Device/D-
1128 |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Pulse duration | 9-12 milliseconds | 9-11 milliseconds | 7.5-14 milliseconds |
5
| Comparison
Elements | Subject Device | Predicate Device 1
(Primary) | Predicate Device 2 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Energy density | 2.65.1J/cm2 | 5.5J/cm2(Max.) | 2.04.0J/cm2 |
| Spot size (size of
treatment
window) | MS-
208B/MS212B/MELSYA-
M6: 3.6cm2
MS-216B/MS-
218B/MELSYA-M7:
3.0cm2 | MELSYA-M5: 3.9cm2
MS-206B: 3.0cm2 | Regulator window:
4.5cm2 ? 2.0cm2
Filter window: 2.5cm2 |
| Delivery device | Direct illumination to
tissue | Direct illumination to
tissue | Direct illumination to
tissue |
| Pulsing control | Finger switch | Finger switch | Finger switch |
| Indication for
use/Intended use | The Home Use IPL
Beauty Device 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. | Home Use IPL Beauty
Device 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. | IPL Home Use Hair
Removal Device is an
over-the-counter
device intended for
removal of unwanted
body and/or facial
hair. |
| Location for use | OTC | OTC | OTC |
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the subject device 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", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
6
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1:2005, MOD Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
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
3) Eye Safety
-
IEC 62471:2006 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with moderate level of concern was 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.
Summary
Based on the above performance as documented in this application, the subject device Home Use IPL Beauty Device was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
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 Home Use IPL Beauty Device is to be concluded substantial equivalent to its predicate devices.