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FDA PRODUCT CODE · CLASS III

OTL — Femtosecond Laser System For Refractive Correction

Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
pma: 1
0
RECALL ENTRIES

Recent clearances

P150040Carl Zeiss Meditec, Inc. · pma2026-05-26

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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