Identity
- Trade Name
- SILSOFT (ELASTOFILCON A) CONTACT LENSES FDA PMA
- Generic Name
- Lenses, soft contact, extended wear FDA PMA
Identifiers
- PMA Number
- P850068 FDA PMA
- FDA Product Code
- LPM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Silsoft (Elastofilcon A) Contact Lenses are classified as Lenses, Soft Contact, Extended Wear, designed for prolonged ocular wear. These silicone hydrogel lenses provide extended comfort and oxygen permeability, enabling continuous or extended use as specified by the manufacturer. They are intended for correction of refractive errors while maintaining corneal health during extended periods of wear.
These lenses are supplied as single-use or reusable, depending on the specific product variant, and are regulated under FDA_PMA with approval number P850068. They are intended for use in ophthalmic settings and must be handled according to sterile procedures. Storage and handling instructions are provided by the manufacturer to ensure proper maintenance and safety. The device adheres to FDA regulation number 886.5925 and is categorized under product code LPM.
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_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P850068 | U | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P850068 24 fields · synced Sep 18, 2026