Epcon Soft (Polymacon) Spherical and Toric Lenses
PMA P880049
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880049 | Date19 Jul 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Lenses, soft contact, daily wear
- PMA Number
- FDA Product Code
- LPL
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
These are soft contact lenses designed for daily wear, available in spherical and toric configurations. The spherical lenses correct refractive errors such as myopia or hyperopia, while the toric lenses address astigmatism by providing distinct optical powers in different meridians. Manufactured from Polymacon, a silicone hydrogel material, they are intended for extended comfort and oxygen permeability to support corneal health during prolonged use.
The lenses are supplied as single-use, sterile disposable products, intended for professional fitting and replacement on a daily basis. They are classified under product code LPL and comply with FDA regulations under PMA number P880049, with subsequent supplements addressing design or specification changes. No additional regulatory status beyond the stated FDA_PMA authorization is implied, and their use is restricted to ophthalmic applications as defined by the advisory committee classification.
Questions
AI-generated answers, 18 Sep 2026
Are these lenses designed for overnight wear, or are they strictly for daily use only?
These lenses are explicitly designed for daily wear only, as stated in the description. They are not intended for extended wear or overnight use, which would require a different classification and regulatory pathway. The product is classified under FDA product code LPL for daily-wear soft contact lenses, reinforcing their single-day use.
How are the lenses supplied, and do they require any special handling before use?
The lenses are supplied as single-use, sterile disposable products, meaning each lens is intended for one-time use only. They come pre-packaged and do not require additional sterilization or cleaning before insertion. The sterile packaging ensures they are ready for immediate professional fitting, eliminating the need for manual sterilization.
What material are these lenses made from, and how does it benefit the wearer?
These lenses are manufactured from Polymacon, a silicone hydrogel material. This material is designed to provide enhanced oxygen permeability, supporting corneal health during prolonged daily wear. The silicone hydrogel composition also contributes to increased comfort, making them suitable for extended periods of use as intended for daily wear.
Are there different models available, and how do I determine which one is right for my prescription?
Yes, these lenses come in two configurations: spherical lenses for correcting myopia or hyperopia, and toric lenses for addressing astigmatism. Spherical lenses provide uniform optical power, while toric lenses offer distinct powers in different meridians to correct irregular corneal curvature. A professional eye care provider should determine the appropriate model based on your prescription and eye health.
What regulatory pathway does this device follow, and how does that affect its use?
This device follows the FDA Premarket Approval (PMA) pathway, as indicated by the PMA number P880049 and subsequent supplements. This means the device has undergone rigorous review to ensure safety and effectiveness for its intended use in ophthalmic applications. The regulatory classification under product code LPL and the advisory committee designation (OP) confirm its use is restricted to professional fitting and replacement for daily-wear soft contact lenses, as defined by the FDA.