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Mport Foldable Lens Placement System

by Chiron Vision Corp.

510(k) K970727

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970727 Date17 Dec 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2098-2017 FDA Class II initiated 5 Apr 2017

    Complaints concerning kinked haptics that were occurring during lens delivery.

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  • Withdrawn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
MSS
Device Class
Class I
Regulation
21 CFR Part 886.4300
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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