1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
FDA 510(k) K261589 · Zhengzhou PZ Laser Slim Technology Co., Ltd.
Submission
- Device name
- 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
Zhengzhou, CN - Received
- May 13, 2026
- Decision date
- September 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
Other 510(k)s with product code GEX
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|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
| K261693 | Diode laser hair removal machine (QDTM-04)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 07/17/2026SE |
More from Beijing Nubway S&T Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)NUV · Traditional | 08/28/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | 08/27/2026SE |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)GEX · Traditional | 10/23/2025SE |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…GEX · Traditional | 07/25/2025SE |
| K250782 | Fractional CO2 Laser MachineGEX · Traditional | 06/12/2025SE |
| K250038 | Muscle Stimulator Device (PZ-100)NGX · Traditional | 05/19/2025SE |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6)GEX · Traditional | 05/14/2025SE |
| K180353 | Diode laser hair removal deviceGEX · Traditional | 04/17/2018SE |
Questions and answers
When was 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) cleared by the FDA?
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) (K261589) received a 510(k) decision of Substantially Equivalent on September 2, 2026, 112 days after the submission was received.
What is the product code of K261589?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.