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FDA 510(k)

EYE SPHERE IMPLANTS

K-Number: K040689 · 2004-06-10

ApplicantOculo Plastik, Inc.
Decision Date2004-06-10
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE SPHERE IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Oculo Plastik, Inc.. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K040689. 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 SPHERE IMPLANTS?

EYE SPHERE IMPLANTS is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Oculo Plastik, Inc.. The 510(k) number is K040689.

When did EYE SPHERE IMPLANTS receive FDA 510(k) clearance?

EYE SPHERE IMPLANTS received FDA 510(k) clearance on 2004-06-10, under 510(k) number K040689.

Who is the listed applicant for EYE SPHERE IMPLANTS?

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

What is the FDA product code for EYE SPHERE IMPLANTS?

The FDA product code for EYE SPHERE IMPLANTS is HPZ.

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Other records listing Oculo Plastik, Inc. 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.

K123764DURETTE OCULAR IMPLANTK112176SILICONE SPHERESK073293DURETTE IMPLANTK934834EPTFE SHEET COVERING FOR OCULAR IMPLANTK915630OPHTIMPLANTK901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES

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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.K082850EYE SPHERESProduct and Educational Services, LLC

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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