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Eye Sphere Implants

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040689

by Oculo-Plastik Inc

Identifiers

510(k) Number
K040689 FDA 510(k)
FDA Product Code
HPZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.3320 FDA 510(k)
Regulation Number
886.3320 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Eye sphere implants are permanent implants used to replace lost volume and provide motility to the ocular prosthesis following enucleation, evisceration, or insertion of a secondary implant. They are made of silicone and are intended for use in ophthalmology.

These ocular implants are supplied non-sterile and must be sterilized before use. They are available in sizes such as 12 mm (0.9 cc) and 18 mm (3.1 cc), and are authorized under FDA 510(k) clearance K040689.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Oculo-Plastik Inc 11-212 Silicone Spheres (12 mm, 0.9 cc), About US - Oculo-Plastik, Inc., Oculo-Plastik Inc 11-218V Silicone Spheres (18 mm, 3.1 cc)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Oculo-Plastik Inc
FDA Applicant
Oculo Plastik, Inc.

Sources (1)

  • FDA 510(k) K040689 24 fields · synced Sep 19, 2026