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)

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

K-Number: K110986 · 2011-05-16

ApplicantOptomed OY
Decision Date2011-05-16
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 is the device name listed in this FDA 510(k) record. The listed applicant is Optomed OY. It received FDA 510(k) clearance on 2011-05-16 under 510(k) number K110986. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1?

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 is a medical device that received FDA 510(k) clearance on 2011-05-16. The listed applicant is Optomed OY. The 510(k) number is K110986.

When did OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 receive FDA 510(k) clearance?

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 received FDA 510(k) clearance on 2011-05-16, under 510(k) number K110986.

Who is the listed applicant for OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1?

The FDA 510(k) record lists Optomed OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1?

The FDA product code for OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 is HKI.

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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Optomed OY as applicant

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.

K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleK163021HAAG-STREIT FUNDUS MODULE 300K132186OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2K092056OPTOMED SMARTSCOPE, MODEL M3-1 EY1

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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.

↑