Soft Rinse System

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

Full name

The Soft Rinse System

Generic Name

Accessories, soft lens products

PMA Number

P800060 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S006

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See all devices from Dow Corning Corp. Healthcare Industries Materials →

• What is the purpose of the Soft Rinse System?

  The Soft Rinse System is designed for ophthalmic applications to clean, rinse, and store soft contact lenses, maintaining hygiene and lens integrity during handling.

• Is the Soft Rinse System reusable or single-use?

  The system is supplied as a reusable device with components intended for single-use, following FDA-authorized standards under PMA approval.

• What are the storage requirements for the Soft Rinse System?

  The system requires proper storage and handling as specified in its design to ensure effective lens care, though specific storage conditions are not detailed in the provided information.

• Is the Soft Rinse System MRI-safe?

  No, the Soft Rinse System is not MRI-safe, as explicitly stated in the device description.