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FDA 510(k)

EYE SPHERES

K-Number: K082850 · 2009-02-27

ApplicantProduct and Educational Services, LLC
Decision Date2009-02-27
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE SPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Product and Educational Services, LLC. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K082850. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE SPHERES?

EYE SPHERES is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Product and Educational Services, LLC. The 510(k) number is K082850.

When did EYE SPHERES receive FDA 510(k) clearance?

EYE SPHERES received FDA 510(k) clearance on 2009-02-27, under 510(k) number K082850.

Who is the listed applicant for EYE SPHERES?

The FDA 510(k) record lists Product and Educational Services, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE SPHERES?

The FDA product code for EYE SPHERES is HPZ.

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

Related Devices (Code: HPZ)

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.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K073293DURETTE IMPLANTOculo Plastik, 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.

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