Yokneam, IL · 7 510(k) clearances · 3 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | Class II | General, Plastic Surgery | 6 | 2022-06-21 |
| QIU | Intense Pulsed Light Device For Managing Dry Eye | Class II | Ophthalmic | 1 | 2021-02-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-22 | Class II | Ongoing | Z-2344-2025 | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incis… | — | The potential for unsterilized product within finished product labeled as sterile. |
| 2025-01-23 | Class II | Ongoing | Z-1290-2025 | (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, La… | — | The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on… |
| 2021-10-14 | Class I | Terminated | Z-0194-2022 | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupli… | — | Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Heal… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2022-06-21 | K211979 | Lumenis Y&R Laser System | GEX | Class II | General, Plastic Surgery |
| 2021-10-19 | K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | GEX | Class II | General, Plastic Surgery |
| 2021-02-23 | DEN200028 | Lumenis Stellar M22 | QIU | Class II | Ophthalmic |
| 2020-12-24 | K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | GEX | Class II | General, Plastic Surgery |
| 2020-10-22 | K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Class II | General, Plastic Surgery |
| 2020-07-16 | K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Class II | General, Plastic Surgery |
| 2020-01-16 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | GEX | Class II | General, Plastic Surgery |