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Promed 38 Sofblu (polymacon) Soft (spherical & Toric) Daily Wear Contact Lens (…
FDA 510(k)Class II (US FDA 510(k))
510(k) K971515
Identifiers
- 510(k) Number
- K971515 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)
Promed 38 Sofblu (polymacon) Soft (spherical & Toric) Daily Wear Contact Lens (… by Biomed Devices Corp. — 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 | K971515 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomed Devices Corp.
Sources (1)
- FDA 510(k) K971515 24 fields · synced Jun 18, 2026