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FDA PRODUCT CODE · CLASS III

LZS — Excimer Laser System

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
pma: 5
0
RECALL ENTRIES

Recent clearances

P060004Carl Zeiss Meditec, Inc. · pma2026-07-01
P020050Alcon Laboratories, Inc. · pma2025-03-05
P990027Technolas Perfect Vision GmbH · pma2025-02-06
P030008Alcon Laboratories, Inc. · pma2025-01-16
P930016Amo Manufacturing USA, LLC · pma2024-08-09

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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