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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State Goggles and pump unit
Technical Method Creation of vacuum with pump
Target Area Ocular
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeQQJ
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5000
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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