OMS Slimline Phaco Handpiece

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K950218 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

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 is the OMS Slimline Phaco Handpiece used for?

  The OMS Slimline Phaco Handpiece is a phacoemulsification device specifically designed for ophthalmic surgical procedures. It facilitates cataract removal by breaking and aspirating clouded lens material through a minimally invasive technique called phacoemulsification. This process reduces trauma to surrounding ocular structures, improving precision and efficiency during surgery.

• Is the OMS Slimline Phaco Handpiece intended for single-use or reuse?

  The OMS Slimline Phaco Handpiece is intended for single-use in sterile surgical settings, though facilities may choose to treat it as reusable or disposable based on their protocols. Adherence to manufacturer guidelines is critical to ensure sterility and proper functionality, as improper handling may compromise performance or safety.

• How should the OMS Slimline Phaco Handpiece be stored?

  The device must be stored according to sterile packaging instructions and environmental controls as outlined by regulatory standards. Proper storage ensures sterility and maintains the device’s integrity for surgical use. Always follow manufacturer guidelines to avoid contamination or degradation.

• Does the OMS Slimline Phaco Handpiece have specific size variations?

  The provided data does not explicitly mention specific size variations for the OMS Slimline Phaco Handpiece. Compatibility with associated phacoemulsification systems determines its use, so check system requirements before selecting or using the handpiece. If size-specific needs arise, consult the manufacturer for compatibility details.

• Is the OMS Slimline Phaco Handpiece MRI-safe?

  The provided information does not explicitly state whether the OMS Slimline Phaco Handpiece is MRI-safe. MRI safety depends on material composition and design, which are not detailed here. If MRI compatibility is required, verify with the manufacturer or consult system documentation to ensure safe use in magnetic environments.