(159 days)
Not Found
No
The summary describes a standard laser system with manual controls for wavelength and energy, and there is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The "Intended Use / Indications for Use" section explicitly states "treatment of benign vascular lesions" and "treatment of benign pigmented lesions," which describes a therapeutic purpose. Additionally, the "Summary of Performance Studies" section mentions compliance with standard IEC 60601-2-22, which covers "therapeutic and diagnostic laser equipment."
No
The device is indicated for therapeutic uses such as tattoo removal and the treatment of various benign lesions, and for surgical uses like incision and ablation of soft tissue. It is not described as being used for diagnosis.
No
The device description explicitly states it is a "laser system" consisting of multiple hardware components (control panel module, main control module, laser power module, temperature and humidity control module, and laser module).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a laser for treating various skin conditions and removing tattoos. These are all procedures performed on the patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description details a laser system that delivers energy to the skin. This aligns with a therapeutic or surgical device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
- Performance Studies: The performance studies focus on non-clinical testing related to safety, electrical compatibility, and biological evaluation (cytotoxicity, irritation), which are typical for devices that interact directly with the body. There are no studies related to diagnostic accuracy or performance on biological samples.
While the device is a medical device, its function is therapeutic and surgical, not diagnostic.
N/A
Intended Use / Indications for Use
The Q Switched Nd: YAG Laser machine (QNHF-01) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers las:er at a wavelength 1064nm or 532nm. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired wavelength and the related output energy via control panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical device Part ! General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-2-22 Edition 3.1 2012-10 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 Edition 2.0 2007-03 Safety of laser products -Part 1: Equipment classification and requirements
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
No clinical study is included in this submission.
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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2025
Beijing Nubway S&T Co., Ltd. % Owen He Consulant Microkn Medical Technology Service (Shanghai) Co.,LtdCompany Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District Shanghai, Shanghai 200040 China
Re: K242943
Trade/Device Name: Q Switched Nd:YAG Laser machine (QNHF-01) 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: September 10, 2024 Received: September 25, 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
1
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 (OS) 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.
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 Re"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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-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@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HTHE -○ Date: 2025.03.03
15:38:28 -05'00'
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
510(k) Number (if known) K242943
Device Name
Q Switched Nd:YAG Laser machine (QNHF-01)
Indications for Use (Describe)
The Q Switched Nd: YAG Laser machine (QNHF-01) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
| 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."
4
| 510(k) Summary | Prepared on: | 2025-02-25 | ||
|---|---|---|---|---|
| 21 CFR807.92(a)(1) | ||||
| Contact Details | ||||
| Applicant Name | Beijing Nubway S&T Co., Ltd. | |||
| Applicant Address | 202,No.5 workshop, No.1 caida 3rd Road NancaiShunyi District, Beijing | |||
| China Beijing Beijin i 100000 China | ||||
| Applicant Contact Telephone | 186-1 0-60418096 | |||
| Applicant Contact | Mr. Xiting Fan | |||
| Applicant Contact Email | 1o15932471@qq.com | |||
| Correspondent Name | Microkn Medical Technology Service (Shanghai) Co.,LtdCompany | |||
| Correspondent Address | Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District, | |||
| Shanghai Shani hai Shanghai 200040 China | ||||
| Correspondent Contact Telephone | 1+86 17721293816 | |||
| Correspondent Contact | Mr. Owen He | |||
| Correspondent Contact Email | fda@microkn.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Q Switched Nd:YAG Laser machine (QNHF-01) | |||
| Common Name | Laser surgical instrument for use in general and plastic surgery and in | |||
| dermatology | ||||
| Classification Name | Powered Laser Surgiical Instrument | |||
| Regulation Number | 878.4810 | |||
| Product Code(s) | GEX | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate# | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K163123 | Q-Switched Nd:YAG Laser Systems | GEX | ||
| Device Description Summary | 21 CFR 807.92(a)(4) | |||
| Q Switched Nd: YAG Laser machine (QNHF-01) is laser system which delivers las:er at a wavelength 1064nm or 532nm. It consists of | ||||
| control panel module, main control module, laser power module, temperature and humidity control module and laser module. The | ||||
| physician is able toselect the desired wavelength and the related output energy via control panel. | ||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |||
| The Q-Switched Nd: YAG Laser machine (QNHF-01) is indicated for use in tattoo removal, treatment of | ||||
| benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, | ||||
| vaporization |
5
K242943
of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532nm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks: Telangiectasias: Spider angioma: Cherry angioma: Spider nevi. -Treatment of Benian Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Indications for Use Comparison
The indications for use are the same as those of the predicate device.
Technological Comparison
The proposed device has technological chat are similar to the predicate device. Both devices have output wavelengt 1064 nm and 532 nm, and both devices have treatment window diameter ranges of 2 - 10 mm. There is a difference of 1 nanosecond the pulsewidth (6 ns for the proposed device vs 5 ns for the proposed device's maximum repetition rate of T Hz is greater than the predicate device's maximum repetition rate of 5 Hz. The proposed device's maximum 532 nm pulse energy is larger (260 ml for the proposed device vs 250 ml for the predicate). These differences however are not considered to raise new,questions regarding safe and effective use of the device for the proposed indications for use.
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:
4EC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical device Part ! General requirements for basic safety and essential performance
· IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
· IEC 60601-2-22 Edition 3.1 2012-10 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 Edition 2.0 2007-03 Safety of laser products -Part 1: Equipment classification and requirements
• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
· ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation
No clinical study is included in this submission.
Based on the technological similarities and the results of performance testing conducted with the device is considered to be substantially equivalent to the predicate device K163123.