Skip to content

Sunsoft (Methafilcon a) Soft (Hydrophilic) Daily Wear Contact Lens

by Sunsoft Corp.

510(k) K964696

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK964696 Date20 Feb 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0348-05 FDA Unclassified (pre-2012) initiated 9 Dec 2004

    Vials containing the lenses are possibly contaminated with residual hydrogen peroxide.

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  • Withdrawn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

Other devices from Sunsoft Corp.