FDA product code · General, Plastic Surgery
GEXPowered Laser Surgical Instrument
Product code GEX covers Powered Laser Surgical Instrument, a Class II device regulated under 21 CFR 878.4810. FDA has cleared 2,872 devices in this code, 73 of them in the last 12 months. Median review time across the 2,872 most recent decisions is 90 days. openFDA lists 200 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4810
- Review panel
- General, Plastic Surgery
- Clearances
- 2,872
What is happening in GEX right now?
GEX (Powered Laser Surgical Instrument) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2554-2026, Z-1694-2026, Z-1695-2026, Z-1558-2026, Z-1130-2026). 18 first-time filers in the last 12 months, including Haidari Beauty Technology (Beijing) Co., Ltd. and ORO Co., Ltd (K253920, K254271, K252048, K252369, K253344). The code is crowded, scoring 100 of 100 — 742 companies hold a clearance here and 73 arrived in the last 12 months (GEX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2554-2026, Z-1694-2026, Z-1695-2026, Z-1558-2026, Z-1130-2026 |
| New entrant | Worth knowing | K253920, K254271, K252048, K252369, K253344 |
| Crowding | Context | GEX:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
What does product code GEX cover?
GEX is FDA's product code for Powered Laser Surgical Instrument, a Class II device regulated under 21 CFR 878.4810.
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.
Source: openFDA device/classification · record GEX · retrieved
How many devices has FDA cleared in GEX?
FDA has cleared 2,872 devices under product code GEX since the 510(k) programme began in 1976, 73 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q) | Rhein Laser Technologies Co., Ltd. | |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | |
| K261701 | 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) | Micro-Energy Medical Technology Co., Ltd. | |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | |
| K260138 | LUNE PureHygiene | Enamel Pure | |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. |
How long does FDA review take for GEX?
The median FDA review time for GEX is 90 days, measured across the 2,872 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GEX?
openFDA lists 200 recall records against product code GEX. A recall record covers one firm's corrective action and may span many device lots.
Z-2554-2026Open, ClassifiedIPG Medical Corporation
Software anomaly that causes a false display of error code 5018.
Z-1694-2026Open, ClassifiedOlympus Corporation of the Americas
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Z-1695-2026Open, ClassifiedOlympus Corporation of the Americas
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.
Z-1558-2026Open, ClassifiedLutronic Corporation
Reports of devices sparking/popping and potentially burning patients.
Z-1130-2026CompletedLEASEIR TECHNOLOGIES SLU
The console label for affected devices is missing the "DANGER" symbol.
Showing the 5 most recently initiated of 200. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GEX?
MAUDE holds 7,316 adverse-event reports naming product code GEX, 1,755 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GEX unusual?
One month sits above GEX's own expected range: 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 141 | Insufficient history | No expected range — too little history | |
| 218 | Insufficient history | No expected range — too little history | |
| 237 | Insufficient history | No expected range — too little history | |
| 183 | Insufficient history | No expected range — too little history | |
| 190 | Insufficient history | No expected range — too little history | |
| 192 | Insufficient history | No expected range — too little history | |
| 175 | Insufficient history | No expected range — too little history | |
| 191 | Insufficient history | No expected range — too little history | |
| 149 | Insufficient history | No expected range — too little history | |
| 154 | Insufficient history | No expected range — too little history | |
| 168 | Insufficient history | No expected range — too little history | |
| 178 | Insufficient history | No expected range — too little history | |
| 171 | Insufficient history | No expected range — too little history | |
| 184 | Insufficient history | No expected range — too little history | |
| 242 | Insufficient history | No expected range — too little history | |
| 178 | Insufficient history | No expected range — too little history | |
| 196 | Insufficient history | No expected range — too little history | |
| 168 | Insufficient history | No expected range — too little history | |
| 174 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 201 | Insufficient history | No expected range — too little history | |
| 148 | 118–231 | Within expected (118–231) | |
| 197 | 96–194 | Above expected (96–194) | |
| 200 | 118–242 | Within expected (118–242) | |
| 224 | 127–258 | Within expected (127–258) | |
| 240 | 124–254 | Within expected (124–254) | |
| 249 | 136–290 | Within expected (136–290) | |
| 265 | 230–470 | Within expected (230–470) | |
| 253 | 157–334 | Within expected (157–334) | |
| 220 | 167–353 | Within expected (167–353) | |
| 266 | 158–335 | Within expected (158–335) | |
| 214 | 156–300 | Within expected (156–300) | |
| 219 | 169–327 | Within expected (169–327) | |
| 191 | 184–366 | Within expected (184–366) | |
| 226 | 131–295 | Within expected (131–295) | |
| 236 | 149–326 | Within expected (149–326) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in GEX.
Who has entered GEX in the last year?
8 companies filed in GEX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Haidari Beauty Technology (Beijing) Co., Ltd. | K253920 | |
| ORO Co., Ltd. | K254271 | |
| Xi'An Taibo Electronic Technology Co., Ltd. | K252048 | |
| Boston Aesthetics, Inc. | K252369 | |
| Speclipse, Inc. | K253344 | |
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | K253007 | |
| Classys, Inc. | K253123 | |
| Baoding Te'Anzhou Electronic Technology Co., Ltd. | K252564 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in GEX?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GEX?
Across the 2,872 most recent decisions, these applicants filed most often in GEX.
| Applicant | Recent clearances |
|---|---|
| Cynosure, Inc. | 80 |
| Sharplan Lasers, Inc. | 66 |
| Quanta System Spa | 57 |
| Laserscope | 49 |
| Trimedyne, Inc. | 48 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in GEX file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Cynosure, Inc. | 85 | 3 |
| Lumenis, Inc. | 60 | 3 |
| Candela Corporation | 53 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GEX
Get an email the morning anything changes in GEX — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.