UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories— 510(k) K203544
Substantially EquivalentLumenis, Ltd.
FDA 510(k) clearance K203544 for UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories, Substantially Equivalent on 2020-12-24. 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
- K202428 — AcuPulse W CO2 Laser Systems, 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.