Moses 200 D/F/L Laser Fiber (M0068130100) +2 more— 510(k) K252529
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K252529 for Moses 200 D/F/L Laser Fiber (M0068130100) +2 more, Substantially Equivalent on 2025-10-30. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Device name as filed
- Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)
- Applicant
- Boston Scientific Corporation
- 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
- Traditional
- Location
- Marlboro, MA, US
Recent devices under product code GEX
view allMore clearances from Boston Scientific Corporation
view allAdverse 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.