Leos Laser and Endoscopy System— 510(k) K240615
Substantially EquivalentBeaver-Visitec International, Inc.
FDA 510(k) clearance K240615 for Leos Laser and Endoscopy System, Substantially Equivalent on 2025-04-03. Applicant: Beaver-Visitec International, Inc.. Device class: 2.
Clearance details
- Applicant
- Beaver-Visitec International, Inc.
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code HQF
view allAdverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
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 K240615
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 K240615.
Data sourced from openFDA. This site is unofficial and independent of the FDA.