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Biocurve Soft (Methafilcon A) Spherical and Toric Soft Contact Lens for Daily Wear

by American Biocurve, Inc.

510(k) K001585

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001585 Date13 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Biocurve Soft (Methafilcon a) Spherical and Toric Soft Contact Lens for Daily Wear (Clear & Blue Visibility Tint, Lathe
510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Biocurve Soft (Methafilcon A) is a spherical and toric soft contact lens designed for daily wear. It is available in both clear and blue visibility tint options and is manufactured using lathe technology. This device is classified as a soft contact lens for daily wear.

The lens is supplied in various sizes and is intended for single-use or daily wear as specified by the manufacturer. It has received FDA 510(k) clearance with the product code LPL and is classified under regulation 886.5925. The device is manufactured by American Biocurve, Inc. and is authorized for use in ophthalmic applications.

Other devices from American Biocurve, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Biocurve Soft contact lens designed for?

    The Biocurve Soft (Methafilcon A) is a spherical and toric soft contact lens specifically designed for daily wear. It is available in both clear and blue visibility tint options and is manufactured using lathe technology for optimal comfort and vision correction.

  • How is the Biocurve Soft contact lens supplied and what are its usage instructions?

    The lens is supplied in various sizes to accommodate different patient needs. It is intended for single-use or daily wear as specified by the manufacturer. Users should follow the specific wearing schedule provided by their eye care professional based on their prescription and eye health requirements.

  • What regulatory approvals does the Biocurve Soft contact lens have?

    The Biocurve Soft contact lens has received FDA 510(k) clearance with the product code LPL and is classified under regulation 886.5925. This clearance indicates that the device is substantially equivalent to other legally marketed contact lenses for daily wear.

  • Who manufactures the Biocurve Soft contact lens?

    The Biocurve Soft contact lens is manufactured by American Biocurve, Inc., located in Grand Junction, Colorado. The company specializes in producing ophthalmic devices, including various types of contact lenses for different vision correction needs.