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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ophthalmic femtosecond laser
Regulation Description Ophthalmic laser.
Definition Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Product CodeOOE
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
LENSX LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 4
OPTIMEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 45
Unintended movement 32
Failure to align 6
Device operates differently than expected 6
Use of Device Issue 3
Failure to cut 3
Device displays error message 3
Poor quality image 2
Output energy incorrect 1
Ambient temperature issue 1
No code available 1
Total Device Problems 103

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