COLD LIGHT SOURCE LOS XL-A 100— 510(k) K952028
Substantially EquivalentLaser-Optik-Systeme GmbH & Co. KG
FDA 510(k) clearance K952028 for COLD LIGHT SOURCE LOS XL-A 100, Substantially Equivalent on 1995-07-27. Applicant: Laser-Optik-Systeme GmbH & Co. KG.
Clearance details
- Applicant
- Laser-Optik-Systeme GmbH & Co. KG
- Product code
- Code GCT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mainz, DE
Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
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.