ClearanceBrief
Panels › Ophthalmic › Product code QQJ · Class 2

Applicator, Negative Pressure, External, Ocular

Regulation 886.5000

1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QQJ

Company510(k)sRecalls
Balance Ophthalmics, Inc.20
Decided510(k)Device and applicantCode
Apr 30, 2026K252455FSYX Ocular Pressure Adjusting Pump
Balance Ophthalmics, Inc.
QQJ
Jun 27, 2024DEN230055FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
Balance Ophthalmics, Inc.
QQJ

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