Home › Device types › GEX
Powered Laser Surgical Instrument
FDA product code GEX · Class 2 · General, Plastic Surgery
6,407
Registered devices
43,846
Adverse events
200
Recalls
2,873
510(k) clearances
Devices with this code
HELIOS 785 Pico 1064 FX Handpiece — Laseroptek Co.,LtdFEMTO LDV — SIE AG, Surgical Instrument EngineeringEpiCare-Zenith — LASETECH LLCETHEREA-MX — VYDENCE MEDICALRevLight — SUBCON MANUFACTURING CORPCLARITY II — Lutronic CorporationDiode 810nm Speed HP For Soprano Pontiac White — ALMA LASERS LTD.NA — OBERON GmbH Fiber TechnologiesOptical Integrity Laser Fiber — OPTICAL INTEGRITY INCWaterlase MDX 300 Laser System — Biolase, Inc.Single use Surgical Optical Fiber — QUANTA SYSTEM SPAProFlex™ — INNOVAQUARTZ LLCSolea — CONVERGENT DENTAL, INC.MFR-272/300-HHz — MED -FIBERS INC.Vascular Solutions Custom Access Kit — Vascular Solutions, Inc.InPulse Dental Laser — INCISIVE, LLCWaterlase iPlus Dental Laser System — Biolase, Inc.GentleYAG LE 12MM RGD Delivery System — Candela CorporationQ-Switch Nd:YAG Metal Treatment Tip 2.5 mm — LUMENIS LTD.LightScalpel — Lightscalpel, LLCAcuPulse™ DUO — LUMENIS LTD.ProFlex™ — INNOVAQUARTZ LLCRefurbished Applicator 1940 — Candela CorporationTwister L — WISDOM MEDICAL TECHNOLOGY, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 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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