The Wrinkle Treatment Device is an Over-the-Counter (OTC), home-use, wearable light based device, and intended for the use in treating full-face wrinkles. Light radiates from the inner surface of the face. This light is generated by LED with two different spectrum wavelengths: red (660nm) and infrared (850nm).

The device is powered by rechargeable Li-battery and controller that is connect to the main unit. The device's power-on/ off, mode switch and treatment time adjustment can be operated by the controller. The device will automatically shut down when the treatment time is over.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrinkle Treatment Device (JM2), structured to address your specific points.

The provided document is a 510(k) Premarket Notification summary for a medical device. It primarily focuses on demonstrating "substantial equivalence" of the new device (Wrinkle Treatment Device JM2) to previously cleared predicate devices, rather than providing detailed clinical efficacy trial results. Therefore, many of your requested points, especially those pertaining to clinical study design (sample size, expert ground truth, adjudication, MRMC studies, effect size, standalone performance, training set details), are not present in this type of submission summary.

This document emphasizes non-clinical testing and comparison to predicates for safety and effectiveness, assuming that the predicate devices have already established their clinical efficacy.

Acceptance Criteria and Study Details for Wrinkle Treatment Device (JM2)

Based on the provided 510(k) Summary, the acceptance criteria are implicitly related to demonstrating compliance with relevant electrical and photobiological safety standards, biocompatibility, and software validation. The study primarily consists of non-clinical testing to meet these standards and to show substantial equivalence to predicate devices, especially regarding technology and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit from Standards)	Reported Device Performance (Summary in Document)
Electrical Safety	Compliance with IEC 60601-1:2020	Device complies with IEC 60601-1:2020
EMC	Compliance with IEC 60601-1-2:2020	Device complies with IEC 60601-1-2:2020
Home Healthcare Env.	Compliance with IEC 60601-1-11:2020	Device complies with IEC 60601-1-11:2020
Light Therapy Safety	Compliance with IEC 60601-2-83:2019	Device complies with IEC 60601-2-83:2019
Photobiological Safety	Compliance with IEC 62471:2006	Device complies with IEC 62471:2006
Battery Safety	Compliance with IEC 62133-2:2017	Device complies with IEC 62133-2:2017
Biocompatibility	Compliance with ISO 10993-5 (Cytotoxicity)	Device complies with ISO 10993-5
	Compliance with ISO 10993-10 (Sensitization)	Device complies with ISO 10993-10
	Compliance with ISO 10993-23 (Irritation)	Device complies with ISO 10993-23
Software Validation	Compliance with FDA Software Guidance	Software verification and validation conducted
Substantial Equivalence	Similar Indications for Use	Same Indications for Use as predicates
	Similar Technological Characteristics	Shared mask design, energy source (LED, Li-ion battery), intended location (full face), similar wavelengths/intensity, same product code (OHS). Differences (treatment size, materials) addressed by testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the actual device samples subjected to non-clinical engineering and biocompatibility testing, not a clinical trial cohort. The document does not specify the number of units tested.
Data Provenance: The report is from Shenzhen Qianyu Technology Co., Ltd. in China. The testing itself would have been conducted in a lab setting, likely by the manufacturer or a contracted testing facility. The data is retrospective in the sense that it's reported after the tests were completed to support the submission. No patient data or clinical trial data provenance (e.g., country of origin, retrospective/prospective clinical study) is mentioned as no clinical study was conducted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. As no clinical study was conducted, there was no "ground truth" to be established by experts in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured parameters against the specified standards (e.g., electrical leakage within limits, specific wavelengths emitted, no cytotoxicity).

4. Adjudication Method for the Test Set

Not applicable. There was no human-read test set requiring adjudication in this non-clinical submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC comparative effectiveness study was not performed. The device is a direct-to-consumer light therapy device, not an AI-assisted diagnostic or imagıng device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI algorithm. Its performance is based on its physical properties and light emission, not computational algorithms analyzing external data.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and biocompatibility testing standards and specifications. For instance:
- Electrical safety: Measured electrical parameters (e.g., leakage current, insulation resistance) compared to IEC 60601-1 limits.
- Photobiological safety: Measured light output parameters (e.g., irradiance, spectral distribution) compared to IEC 62471 limits.
- Biocompatibility: In vitro cellular response (cytotoxicity), skin sensitization, and irritation tests results compared to ISO 10993 criteria.
- Software: Verification and validation against design specifications and FDA guidance.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning sense, as it is not an AI/algorithm-based device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set.

Summary

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April 5, 2024

Shenzhen Oianyu Technology Co., Ltd. Guovang Li Certification Engineer Room 601, Han's Technology Center. No.9988, Shennan Avenue Maling Community, Yuehai Street, Nanshan District Shenzhen, Guangdong 518000 China

Re: K240360

Trade/Device Name: Wrinkle Treatment Device (JM2) 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: OHS Dated: February 3, 2024 Received: February 6, 2024

Dear Guoyang 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 (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/ofdocs/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.

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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).

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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. Hithe Tanisha L. 2024.04.05 Hithe -S 13:02:51 -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

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Indications for Use

Niobium (Cb)

Submission Number (if known)

K240360

Device Name

Wrinkle Treatment Device (JM2)

Indications for Use (Describe)

The wrinkle treatment device (model: JM2) is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

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			Prepared on: 2024-04-05
Contact Details		21 CFR 807.92(a)(1)
Applicant Name		Shenzhen Qianyu Technology Co., Ltd.
Applicant Address		Room 601, Han's Technology Center. No.9988, Shennan Avenue, MalingCommunity, Yuehai Street, Nanshan District Shenzhen Guangdong518000 China
Applicant Contact Telephone		+86 15099998872
Applicant Contact		Mr. Guoyang Li
Applicant Contact Email		liguoyang@jovs-beauty.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name		Wrinkle Treatment Device (JM2)
Common Name		Laser surgical instrument for use in general and plastic surgery and indermatology
Classification Name		Light Based Over The Counter Wrinkle Reduction
Regulation Number		878.4810
Product Code(s)	OHS
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)		Product Code
K230293	TheraFace Mask		OHS
K210954	Synergy		OHS
K162489	RED Light Device		OHS
Device Description Summary			21 CFR 807.92(a)(4)

21 CFR 807.92(a)(5)

Intended Use/Indications for Use

The wrinkle treatment device (model: JM2) is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

Indications for Use Comparison

The subject device and predicate devices (K230293, K210954) have the same indications for use, they are all over-the-counter device and

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intended for the use in treating full face wrinkles.

Technological Comparison

21 CFR 807.92(a)(6)

The technical characteristics of Winkle Treatment Device (JM2) are substantially equivalent to the following aspects:

the same shape design as the primary predicate device (K230293): thev are all mask design.
the same intended location of use: they are all for the entire face.
the same energy source: they all use rechargeable Li-ion battery.
the same energy type: LED
similar wavelength: the wavelength of subject device (660, 850mm ±20nm) is a little different from the primary predicate device (Red: 633 ±10nm, Blue: 415 ±10nm, Red+lR: 633nm±10nm), but the wavelength of the subject device is equivalent to the secondary predicate device (610, 630, 660, 850nm ±5mm), and the device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
similar intensity: the intensity of the subject device is a slightly different from the predicate devices, it is within the maximum range of the reference device (K162489), and the subject device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

The difference between the subject device and the predicate devices mainly includes the following:

different treatment size of subject device (330cm2) is different from the secondary predicate device, but the subject device is a mask design device that is the same as the primary predicate device, so this difference does not raise any new issues of safety or effectiveness.
different main materials: the subject device is composed of silica gel, PVS, ABS, which is different from the predicate devices, but it is solved by biocompatibility test.

Thus, the subject device is determined to be substantially equivalent to the predicate devices.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-clinical testings have been conducted to verify that the Winkle Treatment Device meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results device complies with the following standards:

IEC 60601-1:2020, Medical electrical equipments for basic safety and essential performance IEC 60601-1-2:2020, Medical electrical equipments for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-11:2020, Medical electrical equipments - Part 1-11: 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 60601-2-83:2019, Medical electrical equipments for the basic safety and essential performance of home light therapy equipment

IEC 62471:2006, Photobiological safety of lamps and lamp systems

IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

The device has been tested for biocompatibility, it complies with the following standards.

ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity

ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization

ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation

We have also conducted:

Software verification and validation test according to the FDA "Content of Premarket Submissions for Device Software Functions"

The clinical test is not applicable, there is no clinical data.

The subject device and predicate devices have indications for use, similar technological characteristics. The subject device is as safe, as effective and performs as well as the predicate devices.

Regulation Number and Section

§ 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.