Home › Device types › GEX
Powered Laser Surgical Instrument
FDA product code GEX · Class 2 · General, Plastic Surgery
0
Registered devices
44,261
Adverse events
201
Recalls
2,889
510(k) clearances
Devices with this code
Specialty Delivery System Assembly — Candela CorporationEpic Pro Diode Laser System — Biolase, Inc.HB-272-PL — LASER PERIPHERALS, LLCHemolase Fiber — Micro-Energy Medical Technology Co., LtdMoses™ — LUMENIS LTD.Dornier MedTech — DORNIER MEDTECH AMERICA, INC.Canister HFO-R1234 ZE / 950g, ALUM, 3 Pack (Japan) — Candela CorporationCANLASE-Alexandrite and Nd: Yag laser — Canadian Pioneer Medical Technology CorporationProFlex™ — INNOVAQUARTZ LLCNordlys Mini — Candela CorporationWaterlase iPlus Dental Laser System — Biolase, Inc.Vision One — Lumenis Be, Inc.ProFlex™ — INNOVAQUARTZ LLCSOLTIVE — Gyrus ACMI, LLCDornier MedTech — Dornier MedTech GmbHColoplast — Coloplast A/SVisualase — MEDTRONIC NAVIGATION, INC.Optilite — Convergent Laser TechnologiesQuantaforte — QUANTA SYSTEM SPAWaterlase iPlus Dental Laser System — Biolase, Inc.NA — FORTEC FIBERS, INC.Lumenis Pulse 30H — LUMENIS LTD.MegaBeam — WISDOM MEDICAL TECHNOLOGY, LLCGentleYAG LE Delivery System W/DCD — Candela Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-06 | Lutronic Corporation | Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patie |
| 2026-05-05 | IPG Medical Corporation | Software anomaly that causes a false display of error code 5018. |
| 2026-02-27 | Olympus 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 |
| 2026-02-27 | Olympus 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 |
| 2026-01-27 | Lutronic Corporation | Reports of devices sparking/popping and potentially burning patients. |
| 2025-12-15 | LEASEIR TECHNOLOGIES SLU | The console label for affected devices is missing the "DANGER" symbol. |
| 2025-07-22 | LUMENIS, LTD. | The potential for unsterilized product within finished product labeled as sterile. |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber |
| 2025-05-06 | Olympus Corporation of the Americas | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber |
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