Lumenis M22 System— 510(k) K142860
Substantially EquivalentLumenis, Ltd.
FDA 510(k) clearance K142860 for Lumenis M22 System, Substantially Equivalent on 2015-01-21. Applicant: Lumenis, Ltd.. Device class: 2.
Clearance details
- Applicant
- Lumenis, Ltd.
- Product code
- Product 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
- Traditional
- Location
- Yokneam, IL
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- K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
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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 →
Recalls naming K142860
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142860.
Data sourced from openFDA. This site is unofficial and independent of the FDA.