Biocurve Soft EW Methafilcon A Hydrophilic Contact Lenses
by Wavetouch Technologies, LLC
PMA P860040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP860040 | Date19 Feb 1987 | 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- Withdrawn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
- Trade Name
- Spherical and Toric Daily Wear Soft Contact Lenses
- Generic Name
- Lenses, soft contact, extended wear
- PMA Number
- FDA Product Code
- LPM
- Device Class
- Class III
- Regulation
- 21 CFR Part 886.5925
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Biocurve Soft EW is a hydrophilic soft contact lens manufactured from methafilcon A. These lenses are designed for extended wear to provide vision correction for the user.
This device is manufactured by Wavetouch Technologies, LLC and has received FDA PMA authorization. Please consult with an eye care professional for proper fitting, usage instructions, and storage requirements for these contact lenses.
Questions
AI-generated answers, 18 Sep 2026
What material are the Biocurve Soft EW lenses made of?
The Biocurve Soft EW lenses are composed of methafilcon A, which is a hydrophilic material used in the construction of soft contact lenses.
Are these lenses intended for extended wear?
Yes, these lenses are classified as soft contact lenses for extended wear, as indicated by the product name and the generic device description.
Who is the manufacturer of the Biocurve Soft EW lenses?
The Biocurve Soft EW lenses are manufactured by Wavetouch Technologies, LLC, based in San Diego, California.