Smart Laser Indirect Ophthalmoscope (LIO) +1 more— 510(k) K162837
Substantially EquivalentLumenis, Ltd.
FDA 510(k) clearance K162837 for Smart Laser Indirect Ophthalmoscope (LIO) +1 more, Substantially Equivalent on 2017-02-28. Applicant: Lumenis, Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System
- 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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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.