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 PMA

Extended depth of focus intraocular lens

PMA Number: P210005 · 2026-07-14

ApplicantAcu Focus, Inc.
Decision Date2026-07-14
PMA NumberP210005
Product CodePOE
Device ClassClass 3
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOP

Device Summary

Extended depth of focus intraocular lens is the device name listed in this FDA 510(k) record. The listed applicant is Acu Focus, Inc.. It received FDA 510(k) clearance on 2026-07-14. The device is classified under product code POE. It was reviewed by the OP advisory panel.

Frequently Asked Questions

What is the Extended depth of focus intraocular lens?

Extended depth of focus intraocular lens is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Acu Focus, Inc..

When did Extended depth of focus intraocular lens receive FDA 510(k) clearance?

The clearance date for Extended depth of focus intraocular lens can be found in the official FDA records.

Who is the listed applicant for Extended depth of focus intraocular lens?

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

What is the FDA product code for Extended depth of focus intraocular lens?

The FDA product code for Extended depth of focus intraocular lens is POE.

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.

↑