Devices › Device types
FDA product code GEX · class 2 · General, Plastic Surgery
Powered laser surgical instrument: medical device reports filed with FDA
44,283 reports carry this product code, 1992–2026; 30 brands with a page.
- 44,283
- reports with this product code
- 0.2% of all MAUDE reports
- 2,923
- reports, 12 months to August 2026
- 2,649 in the 12 months before
- 78.1%
- classified as malfunction
- 62.3% across all reports
- 0.2%
- classified as death, as reported
- 0.9% across all reports
Product code GEX is FDA's classification for "Powered laser surgical instrument" (general, Plastic Surgery panel), a class 2 device. 44,283 medical device reports carry this product code, 0.2% of the MAUDE database, from June 1992 to August 2026.
2,923 reports arrived in the 12 months to August 2026, up 10% from 2,649 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (78.1%), injury (20%) and other (1.3%). 30 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Brands with this product code
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| American Medical Systems San Jose | 5,948 | 13.4% |
| Lumenis | 4,830 | 10.9% |
| Wavelight | 4,248 | 9.6% |
| American Medical Systems | 3,935 | 8.9% |
| Quanta System | 1,916 | 4.3% |
| Amo Manufacturing USA | 1,826 | 4.1% |
| American Medical Systems Innovation Center - Silicon Valley | 1,557 | 3.5% |
| Gyrus Acmi | 1,399 | 3.2% |
| Boston Scientific - Marlborough | 1,262 | 2.8% |
| Angiodynamics | 967 | 2.2% |
| Medtronic Navigation | 680 | 1.5% |
| Boston Scientific | 455 | 1% |
| Medtronic Navigation Louisville | 246 | 0.6% |
| Alcon - Irvine Technology Center | 145 | 0.3% |
| Vascular Solutions | 139 | 0.3% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 8,350 | 18.9% |
| Fracturea broken bone | 5,675 | 12.8% |
| Temperature problem | 4,115 | 9.3% |
| Detachment of device or device componentpart of the device came off | 1,808 | 4.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,592 | 3.6% |
| Decrease in suction | 1,551 | 3.5% |
| Device displays incorrect message | 1,488 | 3.4% |
| Failure to align | 1,294 | 2.9% |
| Insufficient device problem information | 1,192 | 2.7% |
| Detachment of device component | 1,082 | 2.4% |
| Defective devicethe device was defective | 929 | 2.1% |
| Improper device output | 820 | 1.9% |
| Thermal decomposition of device | 768 | 1.7% |
| Output problem | 756 | 1.7% |
| Firing problem | 736 | 1.7% |
| Overheating of device | 717 | 1.6% |
| Output below specifications | 668 | 1.5% |
| Device inoperablethe device could not be used | 629 | 1.4% |
| Misfire | 535 | 1.2% |
| Unexpected therapeutic results | 497 | 1.1% |
Questions about powered laser surgical instrument reports
What is product code GEX?
FDA's classification code for "Powered laser surgical instrument", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.
How many reports carry this code?
44,283 reports through August 2026, 2,923 of them in the latest 12 months.
Which brands appear most often?
Greenlight Moxy Fiber Optic (9,058), WaveLight FS200 Femtosecond Laser (3,812), Greenlight Addstat (3,387), FS Disposable Interface (1,374) and Greenlight Hps Bph Fiber Optic (906). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.