Fre-Flex Soft Contact Lens
by Optech, Inc.
PMA P810050
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP810050 | Date20 Nov 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Optech Fre-Flex Soft Contact Lens
- 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
- S002
Overview
AI-generated summary, 18 Sep 2026
The Fre-Flex Soft Contact Lens is a daily-wear soft contact lens designed for ophthalmic use. These lenses are intended to correct refractive errors and improve visual acuity by resting directly on the cornea, providing clear and comfortable vision for extended periods.
These lenses are supplied as single-use, non-sterile devices and are regulated under FDA Premarket Approval (PMA) with the approval number P810050. They are classified as Class II medical devices under the FDA’s regulatory framework, adhering to the requirements outlined in regulation number 886.5925. The lenses are intended for professional fitting and use by trained eye care practitioners.
Other devices from Optech, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses intended for overnight wear, or are they strictly daily-wear only?
The OPTECH Fre-Flex Soft Contact Lens is explicitly designed as a daily-wear device, meaning it is intended for use during waking hours only and should not be worn overnight. The product description and regulatory classification (daily-wear soft contact lenses) confirm this limitation.
How are these lenses supplied, and do they require any special handling before use?
The Fre-Flex Soft Contact Lens is supplied as a single-use, non-sterile device. Since they are non-sterile, they should be handled with clean hands and stored in a clean, dry environment before use. The lenses are intended for professional fitting by trained eye care practitioners, who will provide specific instructions for preparation and application.
What regulatory pathway was followed for approval, and how does this affect their use?
The Fre-Flex Soft Contact Lens received FDA Premarket Approval (PMA) under approval number P810050, indicating a rigorous review process for safety and effectiveness. This approval confirms the device meets FDA standards for correcting refractive errors and improving visual acuity. The PMA pathway ensures these lenses are professionally fitted and used under the supervision of trained eye care practitioners, as required by the regulatory framework.
Are there multiple sizes or models available for these contact lenses?
While the provided data lists multiple FEI numbers (e.g., 3015533540, 3012546757), these are administrative identifiers rather than direct indicators of specific sizes or models. Typically, soft contact lenses like these come in various base curves and diameters to fit different corneal shapes. For exact sizing options, consult the manufacturer’s catalog or your eye care practitioner, as they will determine the appropriate fit based on your prescription and eye measurements.
Can these lenses be reused after removal, or are they strictly for one-time use?
The Fre-Flex Soft Contact Lens is explicitly labeled as single-use, meaning each lens is intended for one application only and should not be reused. This aligns with standard practices for daily-wear soft contact lenses to maintain hygiene and reduce the risk of infection. Discard the lens after removal and replace it with a new one for subsequent wear.