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Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear

by Aspect Vision Care, Ltd.

510(k) K973063

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 NumberK973063 Date26 Aug 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0978-03 FDA Unclassified (pre-2012) initiated 25 Jun 2003

    The actual sphere power of the lens is lower than the labeled value.

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  • Withdrawn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

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