(180 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The focus is on laser technology and compliance with electrical and laser safety standards.
No.
The device is intended for hair removal and permanent hair reduction, which are considered cosmetic purposes, not therapeutic treatments for diseases or medical conditions.
No
The device is described as a hair removal machine, intended for hair reduction, not for diagnosing any medical condition.
No
The device description explicitly states it is a "Handhold Hair Removal Machine" and mentions multiple models, indicating a physical hardware device that uses laser technology for hair removal. The performance studies also reference standards related to electrical safety, laser safety, and biological evaluation, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction on the body. This is a physical treatment applied to the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on a handheld laser device for hair removal.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction 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.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The proposed device is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction
Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories.
The main components list of proposed device shown in Table 1.
| Description | Quantity | Function Description |
|---|---|---|
| Device host | 1 | For removing hair from the body. |
| Power adapter | 1 | Provides stable current and voltage. |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . IEC 60601-1 Medical electrical device Part1: 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 compatibility- Requirements and tests
- IEC 60825-1 Safety of laser products -Part 1: Equipment classification ● and requirements
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity
- . ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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 3, 2023
Ivylaser (Beijing) Technology Co., Ltd. % Eva Li Consultant Microkn Medical Technology Service (Shanghai) Co.,Ltd. Room 901, No. 889, Pinglu Road, Jing'an District Shanghai (Shanghai Jing'an HUAFA Center) Shanghai, 200435 China
Re: K230025
Trade/Device Name: IVYLASER Handhold Hair Removal Machine 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: January 4, 2023 Received: January 4, 2023
Dear Eva 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.
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.
Jianting Wang -S
Jianting Wang Acting 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
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Indications for Use
510(k) Number (if known) K230025
Device Name IVYLASER Handhold Hair Removal Machine
Indications for Use (Describe)
IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent har reduction 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 .
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K230025
1. Contact information
1.1. Applicant
Applicant Name: Ivylaser (Beijing) Technology Co., Ltd.
Address: Room 411, Building 3, No. 2 Shengfang Road, Daxing District,
Beijing
Contact Person: Yuan Xiujuan
Title: General Manager Assistant
Tel: 086-01060299801
Email: yuanxiujuan@oriental-laser.com
1.2. Consultant
Company: Microkn Medical Technology Service (Shanghai) Co., Ltd.
Address: Room 901, No. 889, Pinglu Road, Jing'an District, Shanghai
(Shanghai Jing'an HUAFA Center)
Contact Person: Heather. Wang
Telephone: +86 13166194697
Email: heather.wang@microkn.com
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2. Device information
- Trade Name: IVYLASER Handhold Hair Removal Machine ●
- Model(s): iyoung mini-P, iyoung mini-GY, iyoung mini-GN ●
- Classification: II ●
- Product Code: OHT ●
- Regulation Number: 21 CFR. 878.4810 .
3. Intended use/Indications for Use
IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction 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.
4. Legally Marketed Predicate Device
Product name: SILKPRO Laser Hair Removal System
510(k) Number: K142845
Product Code: OHT
Manufacture: Wuhan Lotuxs Technology Co., Ltd.
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5. Description of the device
The proposed device is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction
Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories.
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The main components list of proposed device shown in Table 1.
| Description | Quantity | Function Description |
|---|---|---|
| Device host | 1 | For removing hair from the body. |
| Power | ||
| adapter | 1 | Provides stable current and voltage. |
Table 1 Main Components list of Proposed Device
6. Non-Clinical Test conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . IEC 60601-1 Medical electrical device Part1: 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 compatibility- Requirements and tests
- IEC 60825-1 Safety of laser products -Part 1: Equipment classification ● and requirements
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity
- . ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
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7.Clinical Test Conclusion
No clinical study is included in this submission.
8.Predicate Devices
Product name: SILKPRO Laser Hair Removal System
510(k) Number: K142845
Product Code: OHT
Manufacture: Wuhan Lotuxs Technology Co., Ltd.
9.Substantially Equivalent (SE) Comparison
The IVYLASER Handhold Hair Removal Machine has been carefully compared to legally marketed devices with respect to intended use, configuration, performance comparison (Table 2), physical specifications comparison (Table 3) and safety comparison (Table 4).
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product | |||
| Code | OHT | OHT | SE |
| 510K | |||
| Number | K230025 | K142845 | / |
| Classificati | |||
| on Name | Laser Instrument, | ||
| Surgical, Powered | Laser Instrument, | ||
| Surgical, Powered | SE | ||
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
Table 1 General Comparison
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| Number | |||
|---|---|---|---|
| Panel | General & Plastic | ||
| Surgery | General & Plastic | ||
| Surgery | SE | ||
| Class | Class II | Class II | SE |
| Intended | |||
| Use | IVYLASER Handhold | ||
| Hair Removal Machine | |||
| is an over-the-counter | |||
| device intended for | |||
| adjunctive use with | |||
| shaving for hair | |||
| removal sustained with | |||
| periodic treatments. | |||
| IVYLASER is also | |||
| intended for permanent | |||
| hair reduction 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. | SILKPRO laser hair | ||
| removal system adopts | |||
| the 810nm diode laser, | |||
| which targets on | |||
| the hair follicle and | |||
| slows the process of hair | |||
| growth. It is used to | |||
| remove unwanted hair | |||
| of body. SILKPRO is | |||
| also intended for | |||
| permanent hair | |||
| reduction 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. | SE, with | ||
| difference in | |||
| wording, | |||
| while the | |||
| actual | |||
| intended | |||
| use are | |||
| the same. | |||
| IVYLASER Handhold | |||
| Hair Removal Machine | SILKPRO is an | ||
| is an over-the-counter | over-the-counter device | ||
| device intended for | intended for adjunctive | ||
| adjunctive use with | use with shaving for hair | ||
| shaving for hair | removal sustained with | ||
| removal sustained with | periodic treatments. | ||
| periodic treatments. | SILKPRO is also | ||
| Indications | IVYLASER is also | intended for permanent | |
| for Use | intended for permanent | hair reduction defined as | SE |
| hair reduction defined | the long-term, stable | ||
| as the long-term, stable | reduction in the number | ||
| reduction in the number | of hairs regrowing when | ||
| of hairs regrowing | measured at 6, 9, and 12 | ||
| when measured at 6, 9, | months after the | ||
| and 12 months after the | completion of a | ||
| completion of a | treatment regime. | ||
| treatment regime. |
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Table 2 Performance Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | SE |
| Wavelength | 808nm | 810nm | Discussion 1 |
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| Max Energy
| Density (Per Sec) | 15.43 J/cm² | 25J/cm² | Discussion 2 |
|---|---|---|---|
| Energy Density | |||
| (Per Sec) | 1.85 J/cm², 3.09 J/cm², | ||
| 6.17J/cm², 9.26 J/cm², | |||
| 15.43 J/cm² | 5J/cm², 10J/cm², | ||
| 15J/cm², | |||
| 20J/cm², 25J/cm² | Discussion 2 | ||
| Laser Beam | 9mm×18mm | 9mm×9mm | Discussion 2 |
| Pulse Width | Maximum: 600ms | ||
| Minimum: 50ms | Maximum: 408.1ms | ||
| Minimum: 68.06ms | Discussion 3 | ||
| Frequency | Maximum: 5hz | ||
| Minimum: 0.5hz | Maximum: 1hz | ||
| Minimum: 0.24hz | Discussion 3 |
Table 3 Physical Specifications Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Operating | |||
| Environment | Temperature: 5~28°C; | ||
| Humidity: |