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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device applicator, negative pressure, external, ocular
Definition External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.
Product CodeQQJ
Regulation Number 886.5000
Device Class 2


Premarket Reviews
ManufacturerDecision
BALANCE OPHTHALMICS, INC.
  GRANTED 1

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