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Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) So…
FDA 510(k)Class II (US FDA 510(k))
510(k) K200528
Identifiers
- 510(k) Number
- K200528 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)
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) So… by Bausch & Lomb Incorporated — 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 | K200528 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
- FDA Applicant
- Bausch + Lomb, Incorporated
Sources (1)
- FDA 510(k) K200528 24 fields · synced Jun 18, 2026