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Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
FDA 510(k)Class II (US FDA 510(k))
510(k) K243953
Identifiers
- 510(k) Number
- K243953 FDA 510(k)
- FDA Product Code
- LPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5925 FDA 510(k)
- Regulation Number
- 886.5925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) by Vizionfocus Inc. — 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 | K243953 | Class II | Active |
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Manufacturer
- Manufacturer
- Vizionfocus Inc.
- FDA Applicant
- Vizionfocus, Inc.
Sources (1)
- FDA 510(k) K243953 24 fields · synced Jun 18, 2026