(28 days)
IPL Hair Remover is an over-the-counter device intended for removal of unwanted body and/or facial hair.
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.
The provided text is a 510(k) Pre-Market Notification for an IPL Hair Remover device. It details the device's technical specifications, comparison to predicate/reference devices, and compliance with standards.
However, it explicitly states, "Clinical performance is not deemed necessary." and "As the modification of subject device ... 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."
This means the submission does not include a new study proving the device meets acceptance criteria for its performance. Instead, it relies on the substantial equivalence principle, arguing that since the device's technological characteristics haven't changed from a previously cleared predicate device, and its intended use is similar to a cleared reference device (just changing from Prescription Use to Over-The-Counter use with a usability study for the new user base), a new clinical performance study is not required.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because the document explicitly states such studies were not conducted for this particular 510(k) submission.
To directly address your request based on the provided text, the answer is that a study proving the device meets acceptance criteria as typically understood for new performance claims (e.g., efficacy in hair removal) was not performed for this submission. The device's "performance" in this context is established through its similarity to a legally marketed predicate device, its compliance with electrical safety and biocompatibility standards, and a usability study for the OTC use.
Here's what can be inferred or explicitly stated from the document regarding the closest relevant points, acknowledging the absence of a direct performance study:
Acceptance Criteria and Device Performance (Inferred from Submission Strategy - Not a Direct Performance Study)
Since no clinical performance study was conducted for this specific submission, there are no reported device performance metrics against acceptance criteria related to hair removal efficacy. Instead, the "acceptance criteria" are effectively met by demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device "Performance" (Based on Equivalence) |
|---|---|
| Safety: | |
| - Compliance with electrical safety standards (IEC 60601-1, -1-11, -2-57) | Device complies with these standards (leveraged from predicate). |
| - Compliance with electromagnetic compatibility (IEC 60601-1-2) | Device complies with this standard (leveraged from predicate). |
| - Biocompatibility (ISO 10993-5, -10) | Materials identical to predicate, thus biocompatible (no new testing). |
| Effectiveness (implied by design similarity): | |
| - Similar energy properties (Wavelength, Max. Fluence, Spot Size, Light Intensity, Pulse duration, Energy medium) | Identical to predicate device: Wavelength 510-1100nm, Max Fluence 4.5 J/cm², Spot Size 4.3 cm², Light Intensity 1.8-4.5 J/cm², Pulse duration 3 ms. |
| - Same design principle and functions | Same as predicate device. |
| Usability for Over-The-Counter (OTC) use: | |
| - User manual and labeling clarity for lay person | Verified by usability study for OTC use. |
Key aspects not found in the document, as no new performance study was undertaken as part of this 510(k):
- Sample sized used for the test set and the data provenance: Not applicable for a performance study. A usability study for OTC use was mentioned, but details on sample size or provenance are not provided.
- Number of experts used to establish the ground truth... and qualifications: Not applicable, as no clinical performance ground truth was established for this submission.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not applicable (this is a hardware device, not an AI algorithm).
- The type of ground truth used: Not applicable for a performance study in this submission.
- The sample size for the training set: Not applicable (no AI/ML algorithm involved, no 'training set').
- How the ground truth for the training set was established: Not applicable.
What was done (explicitly stated):
- Reliance on Predicate Device Data: The submission explicitly states it leverages performance and electrical testing data from the predicate device (K211368) because there have been no changes to the performance of the subject device.
- Usability Study: A usability study was performed to verify the device's suitability for over-the-counter (OTC) use by lay persons, given the change in its intended use from a prescription device. Details of this study (sample size, methodology) are not provided in this summary.
- Biocompatibility: Assessed by demonstrating material identicality to the predicate device, which was already deemed biocompatible.
- Compliance with Standards: The device complies with specified IEC and ISO standards for electrical safety, EMC, and biocompatibility.
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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
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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
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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
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(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
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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 inTechnology Co., Ltd. | Shenzhen Myw inTechnology Co., Ltd. | Shenzhen Beauty EveryMoment intelligent electricCo.,Ltd. |
| K number | TBD | K211368 | K211185 |
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| IPL Hair Remover | IPL Hair Remover | IPL Home Use Hair RemovalDevice | |
|---|---|---|---|
| Product Name | G993, G996, G998 andG885 | G993, G996, G998 andG885 | D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 |
| Regulation &Classification | Classification Name: Lasersurgical instrument for use ingeneral and plastic surgeryand in dermatologyReview Panel: General &Plastic SurgeryProduct Code: OHTRegulation Number:878.4810Regulation Class: 2 | Classification Name:Powered Light Based Non-Laser Surgical InstrumentWith Thermal EffectReview Panel: General &Plastic SurgeryProduct Code: ONFRegulation Number:878.4810Regulation Class: 2 | Classification Name: Lasersurgical instrument for use ingeneral and plastic surgeryand in dermatologyReview Panel: General &Plastic SurgeryProduct Code: OHTRegulation Number:878.4810Regulation Class: 2 |
| Indications forUse | IPL Hair Remover is an over-the-counter device intendedfor removal of unwantedbody and/or facial hair. | The IPL Hair RemoverDevice, Model: G993, G996,G998 and G885 is indicatedfor the removal of unwantedhair under the direction of aphysician, after training by ahealthcare professional. Thedevice is also indicated forthe permanent reduction inhair regrowth, defined as thelong-term, stable reduction inthe number of hairs re-growing when measured at6, 9 and 12 months after the | IPL Home Use Hair RemovalDevice is an over-the-counter device intended forremoval of unwanted bodyand/or facial hair. |
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| completion of a treatmentregime. The device is usedfor 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 ofOutputChannels | One channel | One channel | One channel |
| Output IntensityLevel | 5 levels | 5 levels | / |
| SoftwareControl? | 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 60601-1-11IEC 60601-1-2IEC 60601-2-57 | IEC 60601-1-11IEC 60601-1-2IEC 60601-2-57 | IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57 |
| Biocompatibility | ISO10993-5ISO10993-10 | ISO10993-5ISO10993-10 | ISO10993-5ISO10993-10 |
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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
§ 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.