Diode laser hair removal machine (QDTM-04)
Device Facts
| Record ID | K261693 |
|---|---|
| Device Name | Diode laser hair removal machine (QDTM-04) |
| Applicant | Beijing Nubway S&T Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jul 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Story
Diode laser system for hair removal; utilizes 808 nm pulsed light to achieve selective photothermolysis. System components: main unit (control panel, cooling system, circuit control, semiconductor laser power supply), treatment handpiece, foot switch. Operated by clinicians in professional settings. Output: pulsed laser energy applied to skin. Benefit: long-term, stable reduction in hair regrowth. Clinical decision-making: device provides hair removal treatment based on practitioner assessment of patient skin type and hair characteristics.
Clinical Evidence
No clinical data. Evidence consists of bench testing verifying design specifications (wavelength, energy density, pulse width, spot size, frequency) and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC/TR 60601-4-2, IEC 60825-1, and ISO 10993 (parts 5, 10, 23).
Technological Characteristics
Diode laser (808 nm); Class IV; 2.4 cm² spot size; 3.3-165.6 J total energy; 1.375-69 J/cm² energy density; 10-200 ms pulse width; 1-20 Hz frequency. Includes cooling system and foot switch. Biocompatibility per ISO 10993. Software level of concern: basic.
Indications for Use
Indicated for permanent hair reduction in adults (22 years and older) of all skin types (Fitzpatrick I-VI), including tanned skin.
Regulatory Classification
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.
Predicate Devices
- Diode laser hair removal machine (QDTM-02) (K242951)
Submission Summary (Full Text)
{0}
**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 17, 2026
Beijing Nubway S&T Co., Ltd.
% Owen He
Consulant
Microkn Medical Technology Service (Shanghai)Co.,Ltd Company
Rm. 901, Huafa Center, 889 Pinglu Rd., Jing 'An District
Shanghai, Shanghai 200040
China
Re: K261693
Trade/Device Name: Diode laser hair removal machine (QDTM-04)
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 21, 2026
Received: May 22, 2026
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 (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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K261693 - Owen He
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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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
{2}
K261693 - Owen He
Page 3
(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. 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: 2026.07.17
16:47:54 -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 | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261693 | ? |
| Please provide the device trade name(s). | | ? |
| Diode laser hair removal machine (QDTM-04) | | |
| Please provide your Indications for Use below. | | ? |
| The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
{4}
510(k)#:K261693
510(k) Summary
Prepared on: 2026-07-03
# Contact Details
21 CFR 807.92(a)(1)
Applicant Name
Beijing Nubway S&T Co., Ltd.
Applicant Address
202, No.5 workshop, No.1 caida 3rd Road Nancai Shunyi District, Beijing 101300 China
Applicant Contact Telephone
86-10-60418096
Applicant Contact
Ms. Xiting Fan
Applicant Contact Email
1015932471@qq.com
Correspondent Company Name
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Correspondent Address
Room 901, Huafa Center, 889 Pinglu Road, Jing 'an District, Shanghai 200040 China
Correspondent Contact Telephone
+86 13524136210
Correspondent Contact
Mr. Owen He
Correspondent Contact Email
fda@microkn.com
# Device Name
21 CFR 807.92(a)(2)
Device Trade Name
Diode laser hair removal machine (QDTM-04)
Common Name
Powered Laser Surgical Instrument
Classification Name
Laser surgical instrument for use in general and plastic surgery and in dermatology
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
K242951
Diode laser hair removal machine (QDTM-02)
GEX
# Device Description Summary
21 CFR 807.92(a)(4)
The subject device is a diode laser system consisting of a main unit (housing a control panel, cooling system, circuit control system, and semiconductor laser power supply), treatment handpiece, and foot switch. Treatment is delivered via pulsed 808 nm light to achieve selective photothermolysis.
# Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Page 1 of 2
{5}
510(k)#: K261693
# Indications for Use Comparison
21 CFR 807.92(a)(5)
The indication for use is the same with predicate devices.
# Technological Comparison
21 CFR 807.92(a)(6)
| Device & Predicate Device(s): | K261693 | K242951 |
| --- | --- | --- |
| General Device Characteristics | | |
| Product Code | GEX | GEX |
| Laser Type | Diode Laser | Diode Laser |
| Laser Classification | Class IV | Class IV |
| Wavelength | 808 nm | 808 nm |
| Spot Size | 2.4 cm² (1.2 x 2 cm) | Handpiece 1: 1.44 cm² Handpiece 2: 4 cm² |
| Energy Density | 3.3-165.6 J 1.375-69 J/cm² | Handpiece 1: 3.2-126.7 J 2.222-88 J/cm² Handpiece 2: 4.7-234.1 J 1.175-58.525 J/cm² |
| Pulse Width | 10 – 200 ms | 10 – 200 ms |
| Frequency | 1-20 Hz | 1-20 Hz |
# 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+AMD1:2012+AMD2:2020 (including US National Differences) Medical electrical device Part1: General requirements for basic safety and essential performance
- IEC 60601-1-2 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 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC/TR 60601-4-2 Medical electrical equipment - Par4.2: Guidance and interpretation - electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
- IEC 60825-1 Safety of laser products -Part 1: Equipment classification and requirements
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro 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
- Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software documentation level for this device was determined to be "basic".
- Testing was conducted to validate that the proposed device meets design specifications for wavelength, energy density, pulse width, spot size, and frequency.
o No clinical study is included in this submission.
Based on the data provided, we conclude that the subject device is as safe, as effective, and performs as well as the predicate device.
Page 2 of 2
