(107 days)
Not Found
No
The summary describes a laser hair removal device with different wavelengths and control parameters, but there is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is intended for "temporary hair reduction," which is typically considered a cosmetic procedure rather than a therapeutic one for medical conditions.
No
The "Intended Use / Indications for Use" section states that the device is "intended for temporary hair reduction in Fast Hair Removal Mode(FHR)," which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of a main unit, a foot switch, and a handle-piece, which are hardware components. It also mentions a cooled light outlet and a control panel, further indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary hair reduction." This is a therapeutic or cosmetic purpose, not a diagnostic one.
- Device Description: The description details a laser system designed to emit light pulses for hair removal. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) which is the core of IVD devices.
- Lack of IVD Indicators: There are no mentions of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on safety standards and substantial equivalence to predicate devices used for hair removal, not on diagnostic accuracy or performance metrics relevant to IVD testing (like sensitivity, specificity, etc.).
- Predicate Devices: The predicate devices listed are also laser systems for hair removal, further confirming the device's non-IVD nature.
In summary, the device's purpose, mechanism of action, and the information provided all point to it being a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).
Product codes
GEX
Device Description
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which intended for temporary hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other system functions are controlled by a control panel on the main unit.
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
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)
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 60601-1:2005+A1:2012+A2:2020 Medical electrical device Part1: General requirements for basic safety and essential performance
· EC 60601-1-2:2014+A 1:2020 Medical electrical equipments for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC/TR 60601-4-2:2016 Medical electrical equipment - Par4.2: Guidance and interpretation - electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
· IEC 60601-2-22:2007+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
· IEC 60825-1:2014 Safety of laser products -Part 1: Equipment classification and requirements
· ISO 10993-5 :2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
· ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2024
Ivylaser (Beijing) Technology Co., Ltd % Owen He Consultant Microkn Medical Technology Service (Shanghai) Co.,Ltd. Room 901, No. 889, Pinglu Road, Jing'an District Shanghai. China
Re: K240611
Trade/Device Name: IVYLASER Diode laser hair removal system (IVY-HR-Alloy) 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: GEX Dated: May 13, 2024 Received: May 13, 2024
Dear Owen He:
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 (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/cdrb/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
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 (OS) 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 Advice (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 by Hithe -5 Date: 2024.06.20 14:44:11 -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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
Indications for Use (Describe)
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064mm) into a single handpiece. It is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
| 510(k) Summary | Prepared on: 2024-06-19 | |||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Ivylaser (Beijing) Technology Co.,Ltd | |||
| Applicant Address | Room 411, Building 3, No. 2 Shengfang Road, Daxing District, Beijing | |||
| Beijing Beijing China | ||||
| Applicant Contact Telephone | 010-62258470 | |||
| Applicant Contact | Ms. Yuan Xiujuan | |||
| Applicant Contact Email | yuanxiujuan@oriental-laser.com | |||
| Correspondent Name | Microkn Medical Technology Service (Shanghai) Co., Ltd. | |||
| Correspondent Address | Room 901, No.889, Pinglu Road, Jing'an District, Shanghai | |||
| Shanghai China | ||||
| Correspondent Contact Telephone | +86 13524 136210 | |||
| Correspondent Contact | Mr. He Owen | |||
| Correspondent Contact Email | fda@microkn.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | IVYLASER Diode laser hair removal system (Model: IVY-HR-Alloy) | |||
| Common Name | Laser surgical instrument for use in general and plastic surgery and in | |||
| dermatology | ||||
| Classification Name | Powered Laser Surgical Instrument | |||
| Regulation Number | 878.4810 | |||
| Product Code | GEX | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K230580 | Diode Laser System | GEX | ||
| K222064 | The Alma Soprano Titanium | GEX | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064 nm) into a single handpiece, which intended for temporary | ||||
| hair reduction in Fast Hair Removal Mode(FHR). It consists of a main unit, a foot switch and a handle-piece. The foot switch and the | ||||
| handle switch are activated to start emitting light pulses. The hand-piece has a cooled light outlet. The laser parameters and other | ||||
| system functions are controlled by a control panel on the main unit. |
5
Intended Use/Indications for Use
The Trio-Wavelength Handpiece combines 3 wavelengths (755+810+1064nm) into a single handpiece.lt is intended for temporary hair reduction in Fast Hair Removal Mode(FHR).
Indications for Use Comparison
The indication for use is the same with predicate devices.They are intended for temporary hair reduction .
Technological Comparison
The pulse width, frequency and operation mode of proposed device 1 but similar to predicate device 1 but similar to predicate device2. The wavelength is same as the both predicate devices . The spot size is similar to predicate device1 and different from predicate device2 . The maximum output energy counted by spot size is very close to predicate device is considered would not raise any issues in safety and effectiveness and they can be considered substantially equivalent in safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
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 60601-1:2005+A1:2012+A2:2020 Medical electrical device Part1: General requirements for basic safety and essential performance · EC 60601-1-2:2014+A 1:2020 Medical electrical equipments for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC/TR 60601-4-2:2016 Medical electrical equipment - Par4.2: Guidance and interpretation - electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
· IEC 60601-2-22:2007+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
· IEC 60825-1:2014 Safety of laser products -Part 1: Equipment classification and requirements
· ISO 10993-5 :2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
· ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
No clinical study is included in this submission.
21 CFR 807.92(a)(6)
21 CFR 807 92(a)(5)