(28 days)
No
The description focuses on the IPL technology, a skin proximity sensor, and basic electrical and mechanical characteristics. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, treatment parameter adjustment, or other functions. The performance studies rely on predicate device data and usability studies, not AI/ML model validation.
No.
A therapeutic device is typically intended to treat, cure, or alleviate a disease, injury, or medical condition. This device is described as an "IPL Hair Remover" for "removal of unwanted body and/or facial hair," which is a cosmetic purpose rather than a medical treatment.
No
The device is intended for hair removal based on Intense Pulsed Light (IPL) treatment, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a physical device that includes an IPL device, power supply, and user manual, and incorporates hardware components like a Xenon Lamp and skin proximity sensor.
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 body and/or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description focuses on the mechanism of action (heating the hair root with IPL) and safety features (skin proximity sensor). It does not mention any analysis of biological samples or diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological specimen, which is a core characteristic of IVD devices.
- Input Imaging Modality: While it uses Intense Pulsed Light, this is for treatment (hair removal), not for generating images for diagnostic interpretation.
- Performance Studies: The performance studies mentioned relate to safety and efficacy for hair removal, not diagnostic accuracy (like sensitivity, specificity, etc.).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This IPL Hair Remover does not fit that definition.
N/A
Intended Use / Indications for Use
IPL Hair Remover 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
IPL Hair Remover Device (Model: G993, G996, G998 and G885), is an over-the-counter use device for removal of unwanted body and/or facial hair based on Intense Pulsed Light (IPL) treatment. The device package includes IPL DEVICE, Power supply and User manual. It is supplied by AC power supply (Input 100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device is equipped with a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Remover Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered for pulse emitting. The device can be used for large areas on legs, arms, back and abdomen. The product can flash for 100,000 times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body and/or facial
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.
As there have been no changes to the performance of the subject device from the predicate device, this submission leverages performance and electrical testing provided in previous submission.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 7, 2022
Shenzhen Mywin Technology Co., Ltd. % Jet Li Regulation manager Guangzhou KEDA Biological Tech Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China
Re: K221679
Trade/Device Name: IPL Hair Remover, Model: G993, G996, G998 and G885 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: June 8, 2022 Received: June 9, 2022
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.
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
1
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 mediation-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,
Jianting Wang 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
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Indications for Use
510(k) Number (if known) K221679
Device Name
IPL Hair Remover, model: G993, G996, G998 and G885
Indications for Use (Describe)
IPL Hair Remover 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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510(k) Summary - K221679
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: Shenzhen Mywin Technology Co., Ltd.
Address: 2nd Floor, Building B, New Age gongrong Industrial Zone, No. 2, Shihuan Road,
Shilong community, Shiyan Street, Baoan District, Shenzhen 518103, China
Phone: +86-18902842323
Contact Person (including title): Meiyun Liu (General Manager)
E-mail: Szmywin@163.com
Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl@foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
2 Subject Device Information
Type of 510(k) submission: Special 510(k) Device Modification Common Name: IPL Hair Remover Model: G993, G996, G998 and G885 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 existing device K211368
Company Name:
Common Name: IPL Hair Remover
Model: G993, G996, G998 and G885
Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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
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 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
IPL Hair Remover Device (Model: G993, G996, G998 and G885), is an over-the-counter use device for removal of unwanted body and/or facial hair based on Intense Pulsed Light
5
(IPL) treatment. The device package includes IPL DEVICE, Power supply and User manual. It is supplied by AC power supply (Input 100-240 V AC). The weight of the device is 215.1g, and the size is 188 x 76 x 49mm. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device is equipped with a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Remover Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered for pulse emitting. The device can be used for large areas on legs, arms, back and abdomen. The product can flash for 100,000 times. .
Intended Use ട്
IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.
6 Complied Standards
IPL Hair Remover G993, G996, G998 and G885 complies with the following FDA recognized consensus standards:
- 网 Electrical safety test according to IEC 60601-1, IEC60601-1-11 and IEC 60601-2-57 standards
- 风 Electromagnetic compatibility test according to IEC 60601-1-2 standard
- 风 ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- 区 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
6
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.
As there have been no changes to the performance of the subject device from the predicate device, this submission leverages performance and electrical testing provided in previous submission.
Biocompatibility 9
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.
11 Comparison with predicate device
Compare with predicate device (IPL Hair Remover K211368), the subject device is same in design principle, functions, material and the applicable standards. And the intended use of subject device is same to Reference device K211185. The differences between subject device and predicate devices do not raise any new questions of safety or effectiveness.
| Item | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Manufacturer | Shenzhen Myw in | ||
| Technology Co., Ltd. | Shenzhen Myw in | ||
| Technology Co., Ltd. | Shenzhen Beauty Every | ||
| Moment intelligent electric | |||
| Co.,Ltd. | |||
| K number | TBD | K211368 | K211185 |
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| | IPL Hair Remover | IPL Hair Remover | IPL Home Use Hair Removal
Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | G993, G996, G998 and
G885 | G993, G996, G998 and
G885 | D-1150, D-1171, D-1153, D-
1155, D-1156, D-1126, D-
1178, D-1187 |
| Regulation &
Classification | 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 | 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 | 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 |
| Indications for
Use | IPL Hair Remover is an over-
the-counter device intended
for removal of unwanted
body and/or facial hair. | The IPL Hair Remover
Device, Model: G993, G996,
G998 and G885 is indicated
for the removal of unwanted
hair under the direction of a
physician, after training by a
healthcare professional. The
device is also indicated for
the permanent reduction in
hair regrowth, defined as the
long-term, stable reduction in
the number of hairs re-
growing when measured at
6, 9 and 12 months after the | IPL Home Use Hair Removal
Device is an over-the-
counter device intended for
removal of unwanted body
and/or facial hair. |
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| | | completion of a treatment
regime. The device is used
for adults. | |
|---------------------------------|---------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------|
| | OTC Use | Prescription Use | OTC Use |
| Source Energy | Supplied by external adapter | Supplied by external adapter | Supplied by external adapter |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light |
| | | | Regular window : 530- |
| Wavelength
(nm) | 510nm ~ 1100nm | 510nm ~ 1100nm | 1100nm, 590-1100nm |
| | | | Filter window: 600-1100nm |
| Max. Fluence | Max 4.5 J/cm² | Max 4.5 J/cm² | Max 4.5 J/cm² |
| Spot Size | 4.3 cm² | 4.3 cm² | 4.3 cm² |
| | Level 1: 1.8 J/cm² | Level 1: 1.8 J/cm² | |
| | Level 2: 2.3 J/cm² | Level 2: 2.3 J/cm² | |
| Light Intensity | Level 3: 3.2 J/cm² | Level 3: 3.2 J/cm² | 2.0 to 4.5 J/cm² |
| | Level 4: 4.4 J/cm² | Level 4: 4.4 J/cm² | |
| | Level 5: 4.5 J/cm² | Level 5: 4.5 J/cm² | |
| Pulse duration | 3 ms | 3 ms | 7.5~12 ms |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Pulsing Control | Finger switch | Finger switch | Finger switch |
| Number of
Output
Channels | One channel | One channel | One channel |
| Output Intensity
Level | 5 levels | 5 levels | / |
| Software
Control? | Yes | Yes | / |
| Weight | 215.1g | 215.1g | / |
| Dimensions | 1887649 mm (HWD) | 1887649 mm (HWD) | / |
| Electrical | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| safety, EMC | IEC 60601-1-11
IEC 60601-1-2
IEC 60601-2-57 | IEC 60601-1-11
IEC 60601-1-2
IEC 60601-2-57 | IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 |
| Biocompatibility | ISO10993-5
ISO10993-10 | ISO10993-5
ISO10993-10 | ISO10993-5
ISO10993-10 |
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Sponsor: Shenzhen Mywin Technology Co., Ltd. Subject Device: IPL Hair Remover, Model: G993, G996, G998 and G885
Note
Although the indication for use of subject device is different to predicate device K211368, but it is only to simplify the statement of the legally existing predicate device and remove the prescription use statement, which is not involved with technical specifications. The revised indication for use of subject device in this submission also had been covered by the indication for use of the legally existing predicate device; which is same to Reference device K211185. And the subject device had been verify by usability study for its OTC use. So the difference does not affect the safety and effectiveness.
12 Summary Prepared Date
28 Jun. 2022