(109 days)
No
The summary does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development. The device description focuses on hardware components and basic functions like power levels and cooling.
No.
The 'Intended Use' states the device is for "removal of unwanted body and/or facial hair," which is a cosmetic purpose, not a therapeutic one aiming to treat a disease, injury, or other medical condition.
No
The device is described as an over-the-counter hair removal device with an IPL host and power adapter, and its intended use is 'removal of unwanted body and/or facial hair'. It does not perform any diagnostic functions.
No
The device description explicitly states it includes hardware components such as a lamp cartridge, display screen, buttons, skin sensor, fan, flash button, and DC socket, in addition to the IPL host and power adapter. While software is mentioned in the performance studies, the device is clearly a hardware-based system with integrated software.
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 physical components and features related to delivering IPL for hair removal. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is clearly intended for a physical treatment (hair removal) applied externally to the body, which falls outside the scope of In Vitro Diagnostics.
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 (comma separated list FDA assigned to the subject device)
OHT
Device Description
The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.
IPL Home Use Hair Removal Device includes D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.
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
Not Found
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, Electrical Safety and EMC, Eye Safety, Software Verification and Validation.
Biocompatibility evaluation was conducted in accordance with ISO 10993-1, and included ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation), all of which passed.
Electrical safety and EMC testing passed IEC 60601-1, IEC 60601-1-2, IEC 60601-11, and IEC 60601-2-83.
Eye safety testing passed IEC 62471.
Software documentation consistent with basic documentation level was submitted, and system validation testing demonstrated that all software requirement specifications are met and mitigated to acceptable risk levels.
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 shows 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.
June 18, 2024
Shenzhen Beauty Every Moment intelligent electric Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K240583 Trade/Device Name: IIPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) 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: Mav 20, 2024 Received: May 20, 2024
Dear Youshan Gong:
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 (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Digitally signed b Hithe -S 10:37:34 -04'00
Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K240583
Device Name
IPL Home Use Hair Removal Device (D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K240583 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2024-6-14
-Submitter
Shenzhen Beauty Every Moment intelligent electric Co., Ltd. Rm.301, 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang Avenue No. 164, Zhancheng Community, Fuhai Street, Bao'an District, Shenzhen, Guangdong, China Post code: 518100 Tel .: +86755 3388 3239
Luo Huajun Certification engineer Tel: +86755 3388 3239 E-mail: 309024340@qq.com
ll. Device
Name of Device: IPL Home Use Hair Removal Device Model(s): D-1199, D-T099, D-T018, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation 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 and Reference Device
5
➤ Predicate Device
| Manufacturer | Predicate Device | 510(k)
Number | Approval Date |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------|----------------------|
| Shenzhen Beauty
EveryMoment
intelligent electric
Co.,Ltd. | IPL Home Use Hair
Removal Device, Model(s):
D-1150, D-1171, D-1153, D-
1155, D-1156, D-1126, D-
1178, D-1187 | K211185 | December 20,
2021 |
➤ Reference Device1
| Manufacturer | Reference Device | 510(k)
Number | Approval Date |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------|---------------|
| Shenzhen IONKA
Medical Technology
Co., Ltd. | Hand-held IPL device (IPL
Home Use Hair Removal
Device), Model: FZ-608,
FZ-608G, FZ-100, FZ-200 | K230739 | May 26, 2023 |
► Reference Device2
| Manufacturer | Reference Device | 510(k)
Number | Approval Date |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------|----------------------|
| Foshan Jindi
Electric Appliance
Co.,Ltd | PL Home Use Hair
Removal Device, Model(s):
JD-TM002, JD-TM003,
JDTM012, JD-TM016, JD-
TM022 | K231717 | September 6,
2023 |
IV. Device Description
6
The IPL Home Use Hair Removal Device is the professional IPL in five levels and offers a beauty experience in comfort of your own home as well as has been designed with unique features for simple, relaxed and effective hair removal.
IPL Home Use Hair Removal Device includes D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, D-T019Y, 1196B, D-1196C, D-1196C, D-1196C1, D-T099K, D-T012, D-T012W sixteen models. All have adopted basically identical structure design, consisting of IPL host and power adapter two parts, which the host is mainly composed of lamp cartridge, display screen, power and/or level button, skin sensor, fan, flash button and DC socket. D-T099K, D-T099KM, D-1196B, D-1196W do not contain the lee-Cooling function. D-1199, D-T018, D-T019, D-T003B, D-T003W, D-T019Y, D-T019Y, D-1196C, D-1196C1 have Ice-Cooling function and only perform the hair removal and cold compress function simultaneously. D-T012W have lce-Cooling function and it is able to perform the hair removal and cold compress function simultaneously or separately.
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. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| D-1199, D-T099, D- | ||
| T018, D-T019, D- | ||
| T003B, D-T003W, D- | ||
| T018Y, D-T019Y, D- | ||
| 1196B, D-1196W, D- | ||
| 1196C, D-1196C1, D- | ||
| T099K, D-T099KW, D- | ||
| T012, D-T012W | Host of machine (including air outlet, | |
| treatment window, air inlet, buttons) | PC, ABS, PC+ABS | |
| Crystal, AL |
7
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section "Biocompatibility Discussion"
VII. 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 device. Any minor differences between 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:
| Comparis
on
| Elements | Subject device | Predicate Device | Reference Device 1 | Reference Device 2 |
|---|---|---|---|---|
| Model | D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-T099K, D-T099KW, D-1196C, D-1196C1, D-1196B, D-1196W, D-T012, D-T012W | D-1150, D-1171, D-1153, | ||
| D-1155, D-1156, D-1126, | ||||
| D-1178, | ||||
| D-1187 | FZ-608, FZ- | |||
| 608G,FZ-100,FZ- | ||||
| 200 | JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 | |||
| 510(k) | ||||
| Number | K240583 | K211185 | K230739 | K231717 |
| Trade | ||||
| name | IPL Home Use Hair Removal | |||
| Device | IPL Home Use Hair | |||
| Removal Device | Hand-held IPL | |||
| device (IPL Home | ||||
| Use Hair Removal | ||||
| Device) | IPL Home Use Hair | |||
| Removal Device | ||||
| Comparis | ||||
| on | ||||
| Elements | Subject device | Predicate Device | Reference Device 1 | Reference Device 2 |
| Manufactu | ||||
| rer | Shenzhen Beauty Every | |||
| Moment intelligent electric | ||||
| Co.,Ltd. | Shenzhen Beauty | |||
| EveryMoment intelligent | ||||
| electric Co.,Ltd. | Shenzhen IONKA | |||
| Medical Technology | ||||
| Co., Ltd. | Foshan Jindi Electric | |||
| Appliance Co.,Ltd | ||||
| Regulation | ||||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Product | ||||
| code | OHT | OHT | OHT | OHT |
| Device | ||||
| classificati | ||||
| on | Class II | Class II | Class II | Class II |
| 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. | IPL Home Use Hair | |||
| Removal Device is | ||||
| indicated for the | ||||
| removal of | ||||
| unwanted hair. The | ||||
| device 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 | IPL Home Use Hair | |||
| Removal Device is | ||||
| indicated for the removal | ||||
| of unwanted hair. The | ||||
| device 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. | ||||
| Comparis | ||||
| on | ||||
| Elements | Subject device | Predicate Device | Reference Device 1 | Reference Device 2 |
| the completion of a | ||||
| treatment regime. | ||||
| Prescripti | ||||
| on or OTC | OTC | OTC | OTC | OTC |
| Wavelengt | ||||
| h range | 530-1100nm, | |||
| 590-1100nm | Regular window: 530- | |||
| 1100nm, | ||||
| 590-1100nm | ||||
| Filter window: 600- | ||||
| 1100nm | 510nm~1200nm | JD-TM002,JD-TM003: | ||
| 550-1100nm | ||||
| JD-TM012,JD-TM016: | ||||
| 600-1100nm | ||||
| JD-TM022: | ||||
| 640-1100nm | ||||
| Energy | ||||
| density | 2-6.18 J/cm2 | |||
| (Error: +/-20%) | 2.0~4.5 J/cm² | FZ-608, FZ-608G: | ||
| 3.33 J/cm2 | ||||
| FZ-100: 5.43 J/cm2 | ||||
| FZ-200: 4.5 J/cm2 | JD-TM002,JDTM003,JD- | |||
| TM012, | ||||
| JD-TM016: 2-5 J/cm² | ||||
| JD-TM022: | ||||
| 2-6 J/cm² | ||||
| Spot size | 3.4 cm² | Regular window: | ||
| 3.8cm², 3.6cm², | ||||
| 3.0cm², 1.0cm², 2.0cm², | ||||
| 1.9cm², | ||||
| 1.8cm², | ||||
| Filter window: 3.0cm², | ||||
| 2.0cm² | 3.0cm² | JD-TM002,JDTM003,JD- | ||
| TM012: | ||||
| 3 cm² | ||||
| JD-TM016: | ||||
| 3.3 cm² | ||||
| JD-TM022: 4 cm² | ||||
| Pulse | ||||
| duration | 0.725-1.283ms (+/-20%) | 7.5~12ms | 0.5~0.8 ms | 8-12ms |
8
9
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VIII.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, 'Bioloqical Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
-
ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance ▲
-
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-11 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 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential > performance of home light therapy equipment
3) Eye Safety
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
11
Software documentation consistent with basic documentation level was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and have been mitigated to acceptable risk levels.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Home Use Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device and reference device.