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 device onto the face. This light is generated by VCSEL (Vertical-cavity surface-emitting laser) with two different spectrum wavelengths: red (660nm) and infrared (850nm).

Model JM1 is controlled directly by the button on the main mask body, which can realize device's power on/off and mode switch. The device will automatically shut down when the treatment time is over or when the pure water is run out.

Model JM2B is controlled by a controller that is connect to the main unit and 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. Both models are powered by rechargeable Li-battery.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Wrinkle Treatment Device (JM1, JM2B) lack detailed information regarding specific acceptance criteria and the comprehensive study results (particularly clinical performance) that would typically prove a device meets those criteria. The submission focuses heavily on non-clinical performance data and substantial equivalence to a predicate device based on similar technological characteristics.

Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert adudication, MRMC studies, ground truth establishment), and specific performance metrics are not available in the provided text.

However, I can extract and infer some information based on the typical requirements for a 510(k) submission, especially for a device claiming substantial equivalence to a previously cleared device.

Here's an attempt to describe the acceptance criteria and the study that proves the device meets them, based on the provided document and general FDA 510(k) principles:

Acceptance Criteria and Device Performance (Inferred/General)

Since this is an OTC device intended for treating full-face wrinkles, the acceptance criteria would primarily relate to its safety and efficacy for that stated indication. As per the document, the device (JM1, JM2B) is deemed substantially equivalent to its predicate (JM2), implying that its performance is comparable and acceptable.

Given the nature of the device (light-based for wrinkle treatment), typical acceptance criteria in a clinical study would involve demonstrating a statistically significant reduction in wrinkles or improvement in skin appearance as assessed by objective measures (e.g., standardized photography, wrinkle grading scales) and/or subjective measures (e.g., patient satisfaction, expert assessment). Safety criteria would include the absence of serious adverse events and a low incidence of expected, mild side effects.

Table of Acceptance Criteria and Reported Device Performance

Self-correction: The provided document does not contain a table of explicit acceptance criteria or a detailed report of clinical performance metrics against such criteria. The "Performance Data" section lists non-clinical tests.

However, inferring from the "Substantial Equivalence" claim, the underlying acceptance criteria are that the device is "as safe and as effective as the legally marketed predicate device [K240360 (JM2)] for its intended use".

Characteristic / Performance Metric	Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred from Stated Equivalence)
Effectiveness in treating full-face wrinkles	Comparable efficacy to the predicate device (JM2) in reducing full-face wrinkles. (Likely based on previous predicate's clinical data or general understanding of similar technologies)	Deemed "as effective as" the predicate device for its intended use. No specific metrics provided in this document.
Safety Profile (Adverse Events, Side Effects)	Comparable safety profile to the predicate device (JM2), with acceptable rates of adverse events and mild side effects.	Deemed "as safe as" the predicate device. No specific safety data provided in this document.
Biocompatibility	No cytotoxicity, skin sensitization, or irritation.	Performed and passed ISO 10993-5, -10, -23 for JM1 (JM2B identical to predicate materials, so not needed).
Electrical Safety	Compliance with relevant electrical safety standards.	Performed and passed IEC 60601-1, -1-2, -1-11.
EMC (Electromagnetic Compatibility)	Compliance with relevant EMC standards.	Performed and passed IEC 60601-1-2.
Laser Safety (for VCSEL)	Compliance with laser product safety standards.	Performed and passed IEC 60825-1.
Thermal Performance	Demonstrate appropriate fluence delivery and acceptable spatio-temporal temperature distribution without hazardous thermal accumulation.	Bench testing performed to evaluate fluence contribution and distribution; thermal evaluation performed in ex vivo tissue. Results deemed acceptable.
Software Verification & Validation	Software meets requirements specifications and mitigated hazards to acceptable risk levels (Basic Documentation Level of Concern).	System validation testing demonstrated all software requirements met and hazards mitigated.
Usability	Device is safe and effective for its intended users and use environment.	Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".

Study Details (Based on the provided document, many details are not explicit and would typically be found in the full 510(k) submission, not just the summary letter):

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for any clinical performance testing. The document focuses on non-clinical bench and software testing. For the biocompatibility testing, it mentions "the JM1" (implying the device itself), not a sample size of human subjects.
- Data Provenance: Not specified. If a clinical study was performed for the predicate device, it's highly likely to have been prospective, but the location is not given. For this 510(k) relying on substantial equivalence, the "performance data" listed are primarily non-clinical.
Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable as no direct clinical study results requiring such expert assessment are detailed in this summary. If the predicate device had clinical studies assessed by experts (e.g., dermatologists or plastic surgeons grading wrinkles), that information is not present here.
Adjudication Method for the Test Set:
- Not applicable as no direct clinical study results requiring adjudication are detailed in this summary.
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 evidence of MRMC study: The device described is a light-based wrinkle treatment device, not an AI diagnostic imaging device that typically uses MRMC studies. Therefore, this type of study is not relevant to this device.
If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical treatment device, not a software algorithm for diagnosis that would have a "standalone" performance. Its "performance" refers to its ability to treat wrinkles when used by a human.
The Type of Ground Truth Used:
- For non-clinical performance (safety): The ground truth for biocompatibility was established by recognized international standards (ISO 10993 series). Electrical and laser safety ground truth was established by compliance with IEC standards. Thermal performance ground truth was established through bench testing and ex vivo tissue evaluation against engineering safety limits.
- For efficacy: The ground truth for efficacy is implicitly established by the predicate device's prior clearance for wrinkle treatment. The applicant argues that their new device is "as safe and as effective" as this predicate. No specific new clinical ground truth data for efficacy is presented in this summary document beyond the claim of substantial equivalence.
The Sample Size for the Training Set:
- Not applicable. This device is not an AI/machine learning algorithm that would typically have a "training set" in the context of data. It's a hardware device.
How the Ground Truth for the Training Set was Established:
- Not applicable (as above).

Summary

FDA 510(k) Clearance Letter - Wrinkle Treatment Device

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov

May 1, 2025

Shenzhen Qianyu Technology Co., Ltd.
℅ Riley Chen
Registration Engineer
Feiying Drug & Medical Consulting Technical Service Group
Rm 2401 Zhenye International Business Center, No. 3101-90,
Qianhai Road
Shenzhen, 518052 Cn

Re: K244020
Trade/Device Name: Wrinkle Treatment Device (JM1, JM2B)
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: December 27, 2024
Received: April 2, 2025

Dear Riley Chen:

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.

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.

May 1, 2025

Dear Riley Chen:

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 2

K244020 - Riley Chen Page 2

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.

Page 3

K244020 - Riley Chen Page 3

See the DICE website (https://www.fda.gov/medical-devices/device-advice-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 -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.05.01 19:44:48 -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

Page 4

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K244020

Device Name
Wrinkle Treatment Device (JM1, JM2B)

Indications for Use (Describe)
The Wrinkle Treatment Device 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K244020

Device Name
Wrinkle Treatment Device (JM1, JM2B)

Indications for Use (Describe)
The Wrinkle Treatment Device 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

Shenzhen Qianyu Technology Co., Ltd.
510(k)s –510(k) Summary
Page 1 of 4

510(k) Summary: K244020

"510(k) Summary" as required by 21 CFR Part 807.92.

I. Submitter

Shenzhen Qianyu Technology Co., Ltd.
Room 601, Han's Technology Center. No.9988, Shennan Avenue, Maling Community, Yuehai Street, Nanshan District, Shenzhen, Guangdong, China
Post code: 518000

Guoyang Li
Certification Engineer
Tel: +86 15099998872
Email: liguoyang@jovs-beauty.com

Preparation Date: May 1, 2025

II. Device

Name of Device: Wrinkle Treatment Device
Model(s): JM1, JM2B
Common or Usual Name: Light Based Over the Counter Wrinkle Reduction
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHS
Regulation Number: 21 CFR 878.4810

III. Predicate Device

Manufacturer	Trade Name	510(k) Number	Cleared Date
Shenzhen Qianyu Technology Co., Ltd.	Wrinkle Treatment Device (JM2)	K240360	April 5, 2024

IV. Device Description

Page 6

Shenzhen Qianyu Technology Co., Ltd.
510(k)s –510(k) Summary

510(k) Summary: K244020

"510(k) Summary" as required by 21 CFR Part 807.92.

I. Submitter

Shenzhen Qianyu Technology Co., Ltd.
Room 601, Han's Technology Center. No.9988, Shennan Avenue, Maling Community, Yuehai Street, Nanshan District, Shenzhen, Guangdong, China
Post code: 518000

Guoyang Li
Certification Engineer
Tel: +86 15099998872
Email: liguoyang@jovs-beauty.com

Preparation Date: May 1, 2025

II. Device

III. Predicate Device

Manufacturer	Trade Name	510(k) Number	Cleared Date
Shenzhen Qianyu Technology Co., Ltd.	Wrinkle Treatment Device (JM2)	K240360	April 5, 2024

IV. Device Description

Page 1 of 4

Both models are powered by rechargeable Li-battery.

V. Indications for Use

The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.

VI. Comparison of Technological Characteristics With the Predicate Device

The Wrinkle Treatment Device has the same intended use as the predicate device. The technological characteristics such as wavelength, intensity, are similar to the predicate device. Any minor differences between the subject device and the listed predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is as safe and as effective as the predicate device for its intended use.

Therefore, the Wrinkle Treatment Device may be found substantially equivalent to its predicate device.

Items	Subject device	Predicate device	Difference discussion
K number	Pending	K240360	/
Device trade name	Wrinkle Treatment Device, Model: JM1, JM2B	Wrinkle Treatment Device, Model: JM2	/
Device Class	Class II	Class II	Same
Intended use	The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.	The Wrinkle Treatment Device is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.	Same
Prescription/OTC	OTC	OTC	Same
Shape design	Mask	Mask	Same
No. of Light Sources	JM1: 136, JM2B: 140	140	Comparable
Fluence	JM1: 90/100 mWcm², JM2B: 40/70/100 mWcm²	40/70/100 mWcm²	Comparable
Treatment size	JM1: 260cm², JM2B: 330cm²	330cm²	Comparable
Intended location of use	Entire face	Entire face	Same
Energy type	VCSEL	LED	Different
Wavelength	660, 850nm (±20nm)	660, 850nm ±20nm	Same
Power supply	Rechargeable Li-ion battery	Rechargeable Li-ion battery	Same
Main materials	JM1: Silica gel, PVC, ABS, PC, JM2B: Silica gel, PVC, ABS	Silica gel, PVC, ABS	JM1: Different, JM2B: Same

Page 2 of 4

Page 7

Shenzhen Qianyu Technology Co., Ltd.
510(k)s –510(k) Summary
Page 3 of 4

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Evaluation

This evaluation was not needed for JM2B since material of the subject device (JM2B) and predicate devices is identical in composition and processing.

The biocompatibility evaluation for the JM1 of Wrinkle Treatment Device 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", Document Issued on September 4, 2020", 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 irritation

2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

IEC 60601-1:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2020, Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility
IEC 60601-1-11:2020, 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 60825-1: 2014, Safety of laser products - Part 1: Equipment classification, and requirements

3) Thermal Performance Evaluation

Bench testing was performed to evaluate the fluence contribution of each wavelength.
Bench testing was performed to demonstrate the magnitude and distribution of the fluence that could be delivered to the face for each wavelength.
Thermal performance evaluation was performed in ex vivo tissue to demonstrate the spatio-temporal temperature distribution and thermal accumulation.

4) Software Verification and Validation

Page 8

Shenzhen Qianyu Technology Co., Ltd.
510(k)s –510(k) Summary
Page 4 of 4

Software documentation consistent with Basic Documentation 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.

5) Usability

The product usability has been evaluated and verified according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued on FEBRUARY 2016.

VIII. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Wrinkle Treatment Device is as safe and as effective as the legally marketed predicate device.

Page 4 of 4

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.