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Visulink 900 Argon

by Carl Zeiss, Inc. 510(k)

Active United States

510(k) K952894

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952894 Date14 Aug 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQF
Device Class
Class II
Regulation
21 CFR Part 886.4390
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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