Stellar M22 for Intense Pulsed Light (IPL) and Laser System— 510(k) K193500
Substantially EquivalentLumenis, Ltd.
FDA 510(k) clearance K193500 for Stellar M22 for Intense Pulsed Light (IPL) and Laser System, Substantially Equivalent on 2020-01-16. 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
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- K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
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.