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Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses

by Specialeyes, LLC

510(k) K060821

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

Overview

Specificaleyes 50 and 49 shpere and toric soft contact lenses are a line of prescription lenses designed for daily wear. These lenses are clear, breathable, and comfortable to wear, making them an excellent option for individuals with sensitive eyes or those who want a hassle-free eye care experience. With their unique blend of features and technology, specificaleyes 50 and 49 shpere and toric soft contact lenses provide superior vision quality, comfort, and durability.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK060821 Date18 May 2006ClearedStatusActive

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  • Withdrawn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