(88 days)
Not Found
No
Reasoning: The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a laser system that operates based on fundamental physics (absorption of laser energy leading to thermal effects), rather than data-driven decision-making or learning algorithms.
Yes
The device is indicated for the treatment of various benign cutaneous lesions, pigmented lesions, and tattoo removal, all of which are conditions that a therapeutic device aims to alleviate or cure. The mechanism of action described (localized temperature increase to target tissue to achieve laser treatment effect) also points towards a therapeutic function.
No
Explanation: The device is described as a "Nd: YAG Laser Therapy System" indicated for the "treatment of" various lesions and tattoo removal. The "Device Description" section further elaborates on how the laser beam creates a "thermal effect" on target tissue to "achieve laser treatment effect." There is no mention of the device being used to identify, evaluate, or monitor a medical condition, which are typical functions of a diagnostic device.
No
The device is a physical Nd:YAG Laser Therapy System, explicitly describing hardware components like an optical cavity and an Nd:YAG crystal, and its function involves delivering laser energy to tissue. This is a hardware device, not software-only.
No
The device is a laser therapy system for treating skin lesions and tattoos. It functions by physical interaction with human tissue (thermal effect) rather than by examining specimens derived from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Nd: YAG Laser Therapy System is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.
Product codes
GEX
Device Description
The Nd: YAG Laser Therapy System (Model: QN-1) is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse.
In laser handpiece, there is one optical cavity containing the Nd:YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.
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
Prescription 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
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: 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 disturbances - Requirements and tests
- IEC 60601-2-22: 2019 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: 2007 Safety of laser products - Part 1: Equipment classification, and requirements
- ISO 10993-5: 2009 Biological evaluation of medical device - 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
- IEC TR 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
No clinical study is included in this submission.
Key Metrics
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.
FDA 510(k) Clearance Letter - Nd: YAG Laser Therapy System (QN-1)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 6, 2025
Hebei JT Medical Co., Ltd.
℅ Ray Wang
General Manager
Beijing Believe-Med Technology Services Co., Ltd.
Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd.
FangShan District
Beijing, Beijing 102401
China
Re: K250722
Trade/Device Name: Nd: YAG Laser Therapy System (QN-1)
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: March 10, 2025
Received: March 10, 2025
Dear Ray Wang:
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
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K250722 - Ray Wang Page 2
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 (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
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K250722 - Ray Wang Page 3
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/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: 2025.06.06 13:21:53 -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
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)
K250722
Device Name
Nd: YAG Laser Therapy System (QN-1)
Indications for Use (Describe)
The Nd: YAG Laser Therapy System is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.
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
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"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."
Page 5
510(k) Summary
Premarket Notification 510(k) Submission 510(k) Summary K250722
Page 1 of 4
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K250722
1. Date of Preparation: 03/10/2025
2. Sponsor:
Hebei JT Medical Co.,Ltd.
C12 Hegu Industrial Park, Chaoyang Road, Development Zone, Zhuozhou City, Hebei Province, China, 072750
Contact Person: Ying Wang
Position: General Manager
Tel: +86-13910106157
Email: certification@jontelaser.com
3. Submission Correspondent:
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401
Contact Person: Ray Wang
Position: General Manager
Tel: +86-18910677558
Fax: +86-10-56335780
Email: information@believe-med.com
4. Proposed Device Identification:
Trade Name: Nd: YAG Laser Therapy System
Common Name: Powered Laser Surgical Instrument
Model(s): QN-1
Regulatory Information:
Classification Name: Powered Laser Surgical Instrument
Classification: II
Product Code: GEX
Page 6
Premarket Notification 510(k) Submission 510(k) Summary K250722
Page 2 of 4
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Review Panel: General & Plastic Surgery
Indication For Use Statement:
The Nd: YAG Laser Therapy System is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.
5. Device Description:
The Nd: YAG Laser Therapy System (Model: QN-1) is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse.
In laser handpiece, there is one optical cavity containing the Nd:YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.
6. Predicate Device Identification:
Predicate Device:
510(k) Number: K232716
Product Name: Q-Switched Nd:Yag laser
Manufacturer: Hebei Zhemai Technology Co., Ltd
7. 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: 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 disturbances - Requirements and tests
- IEC 60601-2-22: 2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Page 7
Premarket Notification 510(k) Submission 510(k) Summary K250722
Page 3 of 4
- IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification, and requirements
- ISO 10993-5: 2009 Biological evaluation of medical device - 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
- IEC TR 60601-4-2: 2016 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
8. Clinical Test Conclusion:
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison:
Table 1 Comparison
| ITEM | Proposed Device | Predicate Device (K232716) | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Type of Use | Prescription Use | Prescription Use | SAME |
| Indications for use | The Nd: YAG Laser Therapy System is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. | The Q-switched laser therapy device is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos. | SAME |
| Laser Medium | Nd:YAG | Nd:YAG | SAME |
| Wavelength | 1064 nm; 532 nm | 1064 nm; 532 nm | SAME |
| Output energy | 100mj-1000mj for 1064nm | ||
| 100mj-450mj for 532nm | 100-1000mJ for 1064nm | ||
| 50-500mJ for 532nm | Analysis 1 | ||
| Max. Energy Density | 1064nm: 31.8J/cm² | ||
| 532nm: 15.9 J/cm² | 31.8J/cm² for 1064nm | ||
| 15.9 J/cm² for 532nm | SAME | ||
| Spot Size | 2-10mm | 2-10mm | SAME |
| Pulse Width | 6ns | 6ns | SAME |
| Disinfection | Arms without focusing lenses and probes can be disinfected with a 75% medical grade alcohol wipe. | Arms without focusing lenses and probes can be disinfected with a 75% medical grade alcohol wipe. | SAME |
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Premarket Notification 510(k) Submission 510(k) Summary K250722
Page 4 of 4
| ITEM | Proposed Device | Predicate Device (K232716) | Remark |
|---|---|---|---|
| Laser Class | Class 4 | Class 4 | SAME |
| Cooling method for treated skin area | Closed water circulation | Closed water circulation | SAME |
| Aiming Beam | 650nm (red) Aim at the light: 10mW |