FDA product code GEX: Powered Laser Surgical Instrument
GEX is the FDA product code for powered laser surgical instrument. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2,886 510(k) submissions under GEX, 328 in the last five years, from 791 different applicants. The average 510(k) review took 126 days (median 90); 122 days on average over the last three years. FDA has posted 201 recalls for GEX devices, 38 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Laser Surgical Instrument |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GEX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 67 | 124 |
| 2018 | 51 | 95 |
| 2019 | 41 | 137 |
| 2020 | 52 | 105 |
| 2021 | 53 | 169 |
| 2022 | 60 | 185 |
| 2023 | 52 | 140 |
| 2024 | 82 | 121 |
| 2025 | 83 | 127 |
| 2026 | 51 | 119 |
Compare with all 510(k) review times · Search every GEX clearance
Top GEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cynosure, Inc. | 80 | 2018-02-07 |
| Sharplan Lasers, Inc. | 66 | 1997-12-04 |
| Quanta System Spa | 57 | 2025-06-06 |
| Laserscope | 49 | 2006-12-01 |
| Trimedyne, Inc. | 48 | 2005-12-21 |
786 more applicants have GEX clearances. See the full list in Caduvo.
Most recent GEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252723 | Fotona D.O.O. | Dynamis Pro Family | 2026-09-19 | 387 |
| K241973 | Lumenis Be, Ltd. | SmartIPL_NI System | 2026-09-19 | 806 |
| K261047 | Guilin Kevin Peter Technology Co., Ltd. | Dental Diode Laser Device (Laser-Pen) | 2026-09-18 | 171 |
| K261673 | Beijing Nubway S&T Co., Ltd. | LED Therapy Device (QLXY-01) | 2026-09-17 | 119 |
| K261817 | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) | 2026-09-17 | 108 |
Recalls for GEX devices
201 product recalls in 101 recall events; 38 initiated in the last five years and 45 still open. Most recent: 2026-08-06.
| Year | Recalls |
|---|---|
| 2017 | 19 |
| 2018 | 7 |
| 2019 | 19 |
| 2020 | 3 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 13 |
| 2024 | 9 |
| 2025 | 8 |
| 2026 | 5 |
Frequently asked questions
What is FDA product code GEX?
GEX is the FDA product code for powered laser surgical instrument. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is GEX?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code GEX?
Across 2,886 cleared submissions the average was 126 days from receipt to decision (median 90).
Which companies have the most GEX clearances?
Cynosure, Inc. (80); Sharplan Lasers, Inc. (66); Quanta System Spa (57); Laserscope (49); Trimedyne, Inc. (48).
Have GEX devices been recalled?
Yes: 201 product recalls across 101 recall events; the most recent began 2026-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code GEX
- Run a recall and safety report across every GEX manufacturer
- Watch product code GEX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times