Diode Laser Hair Removal Machine (QDTM-02)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Diode laser hair removal machine EUDAMEDNubway FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- Diode laser hair removal machine EUDAMEDThe semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc. FDA UDI
- Model / Reference
- QDTM-02 EUDAMEDFDA UDI06971679500624 EUDAMED
- Description
- The semiconductor laser therapeutic device is mainly composed of a host, the treatment handle, foot switch, power cord, and accessories. The host consists of a control panel, cooling system, circuit control system, semiconductor laser power supply, etc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971679500624 EUDAMEDFDA UDI
- Basic UDI-DI
- 697167950NUBWAY0629L EUDAMED
- Direct Marketing DI
- 06971679500624 EUDAMED
- 510(k) Number
- FDA Product Code
- GEX FDA 510(k)FDA UDI
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)FDA UDI
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Diode Laser Hair Removal Machine (QDTM-02) is a medical device classified as a laser hair removal system. It emits diode laser energy to selectively target and reduce hair follicles, providing a non-invasive method for hair removal on various body areas.
This device is intended for professional use in clinical or aesthetic settings and is supplied as a reusable medical instrument. It is approved under the FDA’s 510(k) pathway as Substantially Equivalent (SESE) to a predicate device, with additional regulatory compliance under the EU’s Medical Device Regulation (MDR). The machine requires proper training for operation and adherence to manufacturer guidelines for safety and efficacy.
Frequently asked questions
What types of body areas can this laser hair removal machine be used for, and how does it work?
The Diode Laser Hair Removal Machine (QDTM-02) is designed for professional use in clinical or aesthetic settings to provide non-invasive hair removal across various body areas. It emits diode laser energy, which selectively targets hair follicles to reduce hair growth. The device is intended for use on skin where hair removal is desired, though specific areas should be confirmed with the manufacturer’s guidelines to ensure safety and efficacy.
Is this device single-use or reusable, and what maintenance or cleaning procedures should be followed?
The Diode Laser Hair Removal Machine (QDTM-02) is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical or aesthetic settings. Proper maintenance and cleaning are critical to ensure safety and performance. Users must follow the manufacturer’s guidelines for sterilization and upkeep, as outlined in the device’s instructions for use, to prevent contamination and maintain functionality.
How is this device regulated, and what does the FDA’s 510(k) clearance mean for its use?
The Diode Laser Hair Removal Machine (QDTM-02) has been cleared by the FDA under the 510(k) pathway as *Substantially Equivalent (SESE)* to a predicate device, meaning it has been determined to have the same intended use and technological characteristics as an already-approved device. This clearance confirms that the device meets FDA safety and effectiveness requirements for professional laser hair removal in clinical or aesthetic settings. Additionally, it complies with the EU’s Medical Device Regulation (MDR).
Who should operate this device, and what training is required?
This device is intended for professional use only in clinical or aesthetic settings, meaning it should be operated by trained healthcare providers or licensed aestheticians. Proper training is mandatory to ensure safe and effective use, as outlined in the manufacturer’s guidelines. Users must adhere to all operational protocols to minimize risks such as skin damage or improper hair follicle targeting.
What should I consider when storing this device to maintain its performance and sterility?
Since the Diode Laser Hair Removal Machine (QDTM-02) is reusable, it must be stored in a clean, dry environment when not in use to prevent contamination and damage. The manufacturer’s instructions should specify storage conditions, including temperature and handling precautions. If the device requires sterilization between uses, follow the recommended sterilization methods to ensure both performance and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242951 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Nubway S&T Co., Ltd.
Sources (3)
- FDA 510(k) K242951 24 fields · synced Sep 18, 2026
- FDA UDI 6691f426-9de2-4d5e-a9c6-89eab4b1660d 34 fields · synced May 29, 2026
- EUDAMED 278ce2f1-a22a-4c57-bba1-923eaf028a6a 61 fields · synced Aug 4, 2026