Identity
- Trade Name
- FLEXLENS FDA PMA
- Generic Name
- Lenses, soft contact, daily wear FDA PMA
Identifiers
- PMA Number
- N17976 FDA PMA
- FDA Product Code
- LPL FDA PMA
Classification
- Device Class
- Class II 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
- PMA Supplement
- S003 FDA PMA
Flexlens are soft contact lenses designed for daily wear, intended to correct refractive errors by resurfacing the cornea. These lenses are classified as corneal reshaping devices, which gently mold the cornea during sleep to provide clear vision upon removal in the morning.
Flexlens are supplied as single-use, non-surgical ophthalmic devices with FDA Premarket Approval (PMA N17976). They are intended for overnight wear and are regulated under the product code LPL. The lenses are manufactured by Paragon Vision Sciences and are distributed in sterile packaging for direct application to the eye.
Frequently asked questions
Are Flexlens designed for continuous wear or only overnight use?
Flexlens are specifically designed for overnight wear only. They are corneal reshaping devices intended to gently reshape the cornea while the patient sleeps, providing clear vision upon removal in the morning. They are not intended for continuous wear.
How are Flexlens packaged and what does this imply for their use?
Flexlens are supplied in sterile packaging, which means they are pre-sterilized and ready for direct application to the eye without additional sterilization. This ensures safety and hygiene for single-use, as each lens is intended for one patient only.
Are Flexlens reusable or single-use, and what does this mean for clinical workflow?
Flexlens are explicitly described as single-use devices. This means each lens is intended for one patient only and should not be reused, reducing the risk of infection and ensuring consistent performance for each wearer.
What regulatory pathway does Flexlens follow, and what does this indicate about its approval status?
Flexlens follow the FDA Premarket Approval (PMA) pathway, with PMA number N17976. This indicates that the device has undergone rigorous review by the FDA to ensure safety and effectiveness before being approved for commercial distribution.
What types of refractive errors are Flexlens intended to correct?
Flexlens are soft contact lenses designed to correct refractive errors by reshaping the cornea. While the exact types of refractive errors addressed are not detailed in the data, their classification as corneal reshaping devices suggests they are intended for conditions like myopia (nearsightedness) that can be managed through corneal molding.
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. Sources consulted: Paragon Vision Sciences, Our Products | Paragon Vision Sciences, FLEXLENS 510 (k) FDA Approval, FLEXLENS 510 (k) FDA Approval, In Brief: Paragon Vision Sciences - insights.citeline.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | N17976 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA PMA N17976 23 fields · synced Sep 18, 2026