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Vari-Lase Platinum Bright Tip Laser Fiber
FDA 510(k)Class II (US FDA 510(k))
510(k) K091551
Identifiers
- 510(k) Number
- K091551 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Vascular Solutions, Inc. has submitted its 3-year renewal application for FDA clearance of the VARI-LASE PLATINUM BRIGHT TIP LASER FIBER for use in treating vascular conditions.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091551 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA 510(k) K091551 24 fields · synced Jul 22, 2026