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FDA 510(k)

FSYX Ocular Pressure Adjusting Pump

K-Number: K252455 · 2026-04-30

ApplicantBalance Ophthalmics, Inc.
Decision Date2026-04-30
Product CodeQQJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FSYX Ocular Pressure Adjusting Pump is a medical device manufactured by Balance Ophthalmics, Inc.. It received FDA 510(k) clearance on 2026-04-30 under approval number K252455. The device is classified under product code QQJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FSYX Ocular Pressure Adjusting Pump?

FSYX Ocular Pressure Adjusting Pump is a medical device that received FDA 510(k) clearance on 2026-04-30. It is manufactured by Balance Ophthalmics, Inc.. The 510(k) number is K252455.

When was FSYX Ocular Pressure Adjusting Pump approved by the FDA?

FSYX Ocular Pressure Adjusting Pump received FDA 510(k) clearance on 2026-04-30, under approval number K252455.

What company makes FSYX Ocular Pressure Adjusting Pump?

FSYX Ocular Pressure Adjusting Pump is manufactured by Balance Ophthalmics, Inc..

What is the FDA product code for FSYX Ocular Pressure Adjusting Pump?

The FDA product code for FSYX Ocular Pressure Adjusting Pump is QQJ.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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