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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ophthalmic syringe
Regulation Description Piston syringe.
Definition An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.
Product CodeQLY
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTAVIZ, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONGRUENCE MEDICAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU SIGHTNOVO MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
STACLEAR, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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