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 |
|---|---|---|---|
| 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 |
| K260690 | beijing sano laser s and t development co | LumiGlam Laser System (SHE-LSP601-3) | June 4, 2026 |
| K260489 | eufoton | LASEmaR 1500 | May 29, 2026 |
| K260138 | enamel pure | LUNE PureHygiene | May 29, 2026 |
| K253245 | boston aesthetics | Boston 2910 (Boston 2910) | May 21, 2026 |
| K260100 | boston scientific corporation | MOSES Raydar | May 18, 2026 |
| K261214 | speclipse | PICO SHINING (PICO-K; PICOFY) | May 11, 2026 |
| K260974 | nanjing bestview laser s and t co | CO2 Laser Machine (Monica-I,Monica-II) | May 7, 2026 |
| K253251 | leaseir technologies, slu | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Ha | May 4, 2026 |
| K260256 | shanghai apolo medical technology co | Q-Switched Nd: YAG Laser Systems | May 4, 2026 |
| K261094 | asclepion laser technologies | YellowStar | April 29, 2026 |
| K253765 | ddc technologies | VANISH PRO | April 22, 2026 |
| K260153 | nanjing bestview laser s and t co | Q-Switched Nd: YAG Laser System (Glamor Q) | April 20, 2026 |
| K260307 | weifang mingliang electronics co | Diode Laser Therapy Systems (V19) | April 15, 2026 |
| K260017 | shanghai apolo medical technology co | Picosecond Nd:YAG Laser Systems (Model: HS-298) | April 9, 2026 |
| K260375 | sanhe meditech co | Nd: YAG Laser Therapy Systems | March 31, 2026 |
| K260257 | sanhe meditech co | CO2 Laser System | March 28, 2026 |