← Back to catalogue
Fluoroperm 92, 60, 30 And 151 And Paragon Hds, Hds 100 And Thin Rigid Gas Perme…
FDA 510(k)Class II (US FDA 510(k))
510(k) K070637
Identifiers
- 510(k) Number
- K070637 FDA 510(k)
- FDA Product Code
- HQD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5916 FDA 510(k)
- Regulation Number
- 886.5916 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fluoroperm 92, 60, 30 And 151 And Paragon Hds, Hds 100 And Thin Rigid Gas Perme… by Paragon Vision Sciences — Class II — FDA_510K — listed in FDA 510(k)
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 | K070637 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA 510(k) K070637 24 fields · synced Jun 18, 2026