AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories— 510(k) K202428
Substantially EquivalentLumenis, Ltd.
FDA 510(k) clearance K202428 for AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories, Substantially Equivalent on 2020-10-22. Applicant: Lumenis, Ltd.. Device class: 2.
Clearance details
- Applicant
- Lumenis, Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Yokneam, IL
Recent devices under product code GEX
view allMore clearances from Lumenis, Ltd.
view all- K212703 — AcuPulse CO2 Laser System, Delivery Devices and Accessories
- DEN200028 — Lumenis Stellar M22
- K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
- K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.