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Ocu-Flex-49 Spherical, Toric, Aspherical and Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily Wear

by Ocu-Ease Optical Products, Inc.

510(k) K002966

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 NumberK002966 Date8 Nov 2000ClearedStatusActive

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  • Withdrawn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)

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, 25 Sep 2026

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

This device is a soft contact lens designed for daily wear, available in spherical, toric, aspherical, and toric aspherical designs. It is made from Hioxifilcon B material and is intended for vision correction in ophthalmic use.

The device is supplied as a reusable or single-use contact lens for daily wear, with regulatory authorization under FDA 510(k) clearance K002966. It is classified as a Class II medical device under regulation number 886.5925 and is manufactured by Ocu-Ease Optical Products, Inc. in Pinole, California.

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