GEX — Powered Laser Surgical Instrument Class II
FDA product code GEX covers "Powered Laser Surgical Instrument", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GEX
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
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, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241973 | lumenis be | SmartIPL_NI System | September 19, 2026 |
| K252723 | fotona | Dynamis Pro Family | September 19, 2026 |
| K261047 | guilin kevin peter technology co | Dental Diode Laser Device (Laser-Pen) | September 18, 2026 |
| K261673 | beijing nubway s and t co | LED Therapy Device (QLXY-01) | September 17, 2026 |
| K261817 | zhengzhou pz laser slim technology co | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | September 17, 2026 |
| K262877 | olympus surgical technologies america | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPul | September 16, 2026 |
| K262426 | wuhan pioon technology co | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | September 10, 2026 |
| K261562 | sanhe lefis electronics co | Diode Laser Therapy System | September 10, 2026 |
| K261589 | zhengzhou pz laser slim technology co | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | September 2, 2026 |
| K262269 | beijing mega beauty technology co | CO2 Laser System (MBT- CO2 Laser) | September 1, 2026 |
| K261821 | zhengzhou pz laser slim technology co | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | August 27, 2026 |
| K261964 | elesta | ECHOLASER X4 | August 19, 2026 |
| K262070 | hebei zollvan medical technology co | Diode Laser Therapy Systems (DL612A) | August 19, 2026 |
| K261841 | beijing nubway s and t co | Q Switched Nd:YAG Laser machine (QLQW-01) | August 11, 2026 |
| K261221 | olympus surgical technologies america | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPul | July 24, 2026 |
| K261738 | rhein laser technologies co | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | July 21, 2026 |
| K261693 | beijing nubway s and t co | Diode laser hair removal machine (QDTM-04) | July 17, 2026 |
| K261674 | beijing nubway s and t co | Skin Air Cooling System (QALF-01) | July 16, 2026 |
| K261701 | micro-energy medical technology co | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | June 18, 2026 |
| K261570 | cynosure | PICOSURE WORKSTATION | June 17, 2026 |