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SLT Select Fiber Delivery System and Contact Tips - ERP4
FDA 510(k)Class II (US FDA 510(k))
510(k) K243121
Identifiers
- 510(k) Number
- K243121 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- TCRH 7-SMA FDA 510(k)FEF 2.2-SMA FDA 510(k)CFE 0.6-SMA FDA 510(k)SSRH 8Z-SMA FDA 510(k)SSRH 4-SMA FDA 510(k)SSRH 6-SMA FDA 510(k)SSRH 9-SMA FDA 510(k)SSRH 10-SMA FDA 510(k)SSRH 11-SMA FDA 510(k)SSRH 7L-SMA FDA 510(k)TCRH 7Z-SMA FDA 510(k)FEF 1.8-SMA FDA 510(k)CFE 0.55-SMA FDA 510(k)CFE 0.36-SMA FDA 510(k)LAL 550-SMA FDA 510(k)LAL 550Z-SMA FDA 510(k)LAL 365-SMA FDA 510(k)LAL 365Z-SMA FDA 510(k)ER2 FDA 510(k)ERP2 FDA 510(k)GR2 FDA 510(k)GRP2 FDA 510(k)ER4 FDA 510(k)ERP4 FDA 510(k)GR4 FDA 510(k)GRP4 FDA 510(k)ER6 FDA 510(k)ERP6 FDA 510(k)GR6 FDA 510(k)GRP6 FDA 510(k)ER8 FDA 510(k)ERP8 FDA 510(k)GR8 FDA 510(k)GRP8 FDA 510(k)ER10 FDA 510(k)ERP10 FDA 510(k)GR10 FDA 510(k)GRP10 FDA 510(k)ER12 FDA 510(k)ERP12 FDA 510(k)GR12 FDA 510(k)GRP12 FDA 510(k)MD2.5 FDA 510(k)MD3.5 FDA 510(k)HP1.0 FDA 510(k)MTP1.5 FDA 510(k)MTP3.5 FDA 510(k)MTRG1.5 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)
SLT Select Fiber Delivery System and Contact Tips - ERP4 by Jiangxi Medex Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 49 models
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 | K243121 | Class II | Active |
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Manufacturer
- Manufacturer
- Jiangxi Medex Technology Co., Ltd.
Sources (1)
- FDA 510(k) K243121 24 fields · synced Jun 18, 2026