Hydrasoft (East) and Hydrasoft Toric(East) (Methafilcon B) Daily Wear Soft Hydrophilic Contact Lens
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K962185 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)
The Hydrasoft (East) and Hydrasoft Toric(East) are soft hydrophilic contact lenses made of methafilcon B, designed for daily wear. These lenses are intended to correct vision by covering the cornea and providing optical clarity.
These contact lenses are supplied as a single-use product and should be stored according to manufacturer guidelines. The device is classified under product code LPL and has received FDA 510(k) clearance with the authorization number K962185.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962185 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K962185 24 fields · synced Sep 21, 2026