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Kurz Upper Eyelid Implant- Platinum/Iridium, Models Regular 4007 003-007, Special 4007 002, 4007 008-010

by Heinz Kurz GmbH Medizintechnik

510(k) K011115

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK011115 Date2 May 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 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  • Withdrawn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
MML
Device Class
Class II
Regulation
21 CFR Part 886.5700
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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