Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Balance Ophthalmics, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) 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. The listed applicant is Balance Ophthalmics, Inc.. The 510(k) number is K252455.

When did FSYX Ocular Pressure Adjusting Pump receive FDA 510(k) clearance?

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

Who is the listed applicant for FSYX Ocular Pressure Adjusting Pump?

The FDA 510(k) record lists Balance Ophthalmics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

↑