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Summit Krumeich-Barraquer Microkeratome

by Summit Technology, Inc.

510(k) K980675

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980675 Date22 Dec 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0612-03 FDA Unclassified (pre-2012) initiated 18 Nov 2002

    Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.

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  • Withdrawn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
HNO
Device Class
Class I
Regulation
21 CFR Part 886.4370
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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