OMS Silicone Oil Injector

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K844895 ↗

FDA Product Code

LWL

Device Class

Class III

Regulation

21 CFR Part 886.4275

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Aspiration Reversal Control (Arc) Module

  Class II

  FDA 510(k) K870068 Active Cleared 12 Feb 1987

• Oms Infusion Cannula Assemble

  Class I

  FDA 510(k) K813481 Active Cleared 22 Jan 1982

• Diplomax

  Class II

  FDA 510(k) K946054 Active Cleared 11 Jul 1995

• Oms Infusion-Aspiration Handle

  Class II

  FDA 510(k) K813500 Active Cleared 4 Feb 1982

• Oms/Gonvers Retinal Perforator

  Class I

  FDA 510(k) K844448 Active Cleared 21 Aug 1985

• Ophthalmic Surgical System

  Class II

  FDA 510(k) K935223 Active Cleared 14 Mar 1994

See all devices from Optical Micro Systems, Inc. →

• What types of eye surgeries is the OMS Silicone Oil Injector specifically designed for, and how does it help during these procedures?

  The OMS Silicone Oil Injector is designed for vitreoretinal surgeries such as vitrectomy or retinal detachment repair. It delivers sterile silicone oil into the eye to restore or maintain intraocular pressure and support the structural integrity of the eye during these procedures, ensuring stability while the retina heals.

• Is the OMS Silicone Oil Injector meant for repeated use, or is it intended to be used only once per patient?

  The OMS Silicone Oil Injector is explicitly labeled as a single-use device. This ensures sterility and functionality are maintained for one procedure per patient, reducing the risk of contamination or cross-infection in clinical settings.

• What storage conditions should be followed for the OMS Silicone Oil Injector to preserve its sterility and performance?

  While specific storage instructions aren’t detailed in the regulatory data, as a sterile single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines (provided in the packaging) to maintain sterility until use.

• Does the OMS Silicone Oil Injector come in different sizes or models, and if so, how would a clinician determine the appropriate one for a patient?

  The regulatory data does not specify varying sizes or models for the OMS Silicone Oil Injector. Clinicians should rely on the manufacturer’s instructions or surgical protocol to determine the appropriate volume or type of silicone oil to inject, as this device is designed for precise delivery rather than interchangeable components.

• How was the OMS Silicone Oil Injector evaluated by the FDA, and what does its clearance status imply about its safety and effectiveness?

  The OMS Silicone Oil Injector was granted FDA 510(k) clearance under the Traditional review pathway, with a decision of *Substantially Equivalent* to a predicate device. This implies the FDA determined it has the same intended use, technological characteristics, and performance as a previously cleared device, ensuring it meets regulatory standards for safety and effectiveness in ophthalmic applications.