(244 days)
Not Found
No
The summary describes a standard IPL device with a skin sensor and safety features. There is no mention of AI, ML, or any learning or adaptive algorithms. The software validation mentioned is for basic device functionality and safety, not AI/ML.
No
The device is intended for cosmetic hair removal, not for treating any disease, injury, or medical condition.
No
The device is intended for hair removal, which is a treatment or cosmetic procedure, not a diagnostic one.
No
The device description clearly states it is a physical device utilizing Intense Pulsed Light (IPL) technology with hardware components like a Xenon lamp, skin sensor, and external power adapter. While it mentions software verification and validation, this is for the control of the hardware, not a standalone software device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The IPL Home Use Hair Removal Device uses light energy to reduce hair growth on the body and face. It interacts directly with the skin and hair follicles.
- Intended Use: The intended use is for "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
- Mechanism of Action: The device works by targeting the pigment in hair follicles with light, not by analyzing biological samples.
The information provided clearly describes a device that is applied externally to the body for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
“IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.”
Product codes
OHT
Device Description
“The IPL Home Use Hair Removal 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 Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
“personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user.” / Home Healthcare Environment
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)
“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 devic4 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 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10 Biological Evaluation of Medical Devices –Par t 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 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 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 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 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.
Summary
Based on the above performance as documented in this application, the subject device IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device.”
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.
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 & 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.
December 20, 2021
Shenzhen Beauty Every Moment intelligent electric Co., Ltd. % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address
Re: K211185
Trade/Device Name: IPL Home Use Hair Removal Device 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 19, 2021 Received: November 22, 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 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.
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) K21185
Device Name
IPL Home Use Hair Removal Device, Model(s): D-1150, D-1171, D-1153, D-1156, D-1126, D-1178, D-1187
Indications for Use (Describe)
IPL Home Use Hair Removal Device 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
''510(k) Summary'' as required by 21 CFR Part 807.92.
Date: 2021-12-17
I. Submitter
Shenzhen Beauty Every Moment intelligent electric Co.,Ltd. Rm. 501, Bldg. 4, Haoer Jiashitai Technology Park. Fengtang Avenue No. 164, Heping Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518100 Tel .: +86 755 3325 3598
LUO HUAJUN Certification enginner Tel: +86 755 3325 3598 Email: 309024340@qq.com
II. Device
Name of Device: IPL Home Use Hair Removal Device Model(s): D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 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
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen | |||
| Technology Co., Ltd. | Bosidin | ||
| IPL Home Use Hair Removal | |||
| Device/D-1128 (Primary) | K192432 | Nov. 08, 2019 | |
| CyDen Limited. | iPulse SmoothSkin Gold | ||
| Hair Removal System | K160968 | Apr.04, 2016 |
IV. Device Description
The IPL Home Use Hair Removal 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 Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The
4
device contains a Xenon lamp and a skin 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.
The IPL Home Use Hair Removal Device includes D-1150, D-1171, D-1153, D-1155, D-1156, D-1126, D-1178, D-1187 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents and the number of button, lamp cartridge's quantity and appearance; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.
V. Indications for Use
IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
VI. Comparison of Technological Characteristics With the Predicate Device
The IPL Home Use Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices. 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 IPL Home Use Hair Removal Device may be found substantially equivalent to its predicate device.
IPL Home Use Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:
| Comparison
| Elements | Subject Device | Predicate Device | |
|---|---|---|---|
| K192432 | |||
| (Primary) | K160968 | ||
| K Number | Pending | K192432 | K160968 |
| Trade name | IPL Home Use Hair Removal | ||
| Device/D-1150, D-1171, D-1153, | |||
| D-1155, D-1156, D-1126, D-1178, | |||
| D-1187 | IPL Home Use Hair | ||
| Removal Device/D- | |||
| 1128 | iPulse SmoothSkin | ||
| Gold Hair Removal | |||
| System | |||
| Wavelength | |||
| range | Regular window: 530-1100nm, | ||
| 590-1100nm | |||
| Filter window: 600-1100nm | 510-1100nm | 510-1100nm | |
| Energy | |||
| medium | Xenon Arc Flashlamp | Xenon Arc | |
| Flashlamp | Xenon Arc | ||
| Flashlamp | |||
| Energy density | 2.0~4.5 J/cm² | 2.0~4.0 J/cm² | 3~6 J/cm² |
| Spot size | Regular window: 3.8cm², 3.6cm², | ||
| 3.0cm², 1.0cm², 2.0cm², 1.9cm², | |||
| 1.8cm², | |||
| Filter window: 3.0cm², 2.0cm² | 4.5, 2.0, 2.5cm² | 3 (3cm by 1cm) |
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| Comparison | Predicate Device | ||
|---|---|---|---|
| Elements | Subject Device | K192432 | |
| (Primary) | K160968 | ||
| Pulse duration | 7.5~12ms | 7.5-14.5ms | 2-10ms |
| Pulsing control | Finger switch | Finger switch | Finger switch |
| Delivery device | Direct illumination to tissue | Direct illumination | |
| tissue | Direct illumination | ||
| tissue | |||
| Indication | |||
| for | |||
| use/Intended | |||
| use | IPL Home | ||
| Use Hair Removal | |||
| Device is | |||
| an over-the-counter | |||
| device intended for removal of | |||
| unwanted body and/or facial hair. | IPL Home Use Hair | ||
| Removal Device is | |||
| an over-the-counter | |||
| device intended for | |||
| removal | |||
| of | |||
| unwanted | |||
| body | |||
| and/or facial hair. | 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 | |||
| regrowing | |||
| when | |||
| measured at 6, 9 | |||
| and 12 months after | |||
| the completion of a | |||
| treatment regime. | |||
| 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 devic4 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 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
6
-
ISO 10993-10 Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 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 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 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 IPL Home Use Hair Removal 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 IPL Home Use Hair Removal Device is to be concluded substantial equivalent to its predicate devices.