Softherm Sol.

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

Generic Name

Accessories, soft lens products

PMA Number

N18078 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002

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See all devices from Advanced Medical Optics, Inc. →

• What is the SoftTherm Sol. used for in clinical practice?

  The SoftTherm Sol. is a reusable thermal solution accessory designed specifically for ophthalmic use to prepare and maintain soft contact lenses. It applies controlled heat to sterilize and condition lenses before patient use, ensuring they are properly sanitized and ready for wear.

• Is the SoftTherm Sol. intended for single-use or reusable applications?

  The SoftTherm Sol. is explicitly described as a reusable thermal solution accessory, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance. It is not intended for single-use.

• What regulatory pathway was followed for the SoftTherm Sol., and what does that mean for its use?

  The SoftTherm Sol. was approved through the FDA’s Premarket Approval (PMA) process under PMA number N18078, which is the highest regulatory standard for medical devices in the U.S. This means it has undergone rigorous clinical evaluation to ensure safety and effectiveness for its intended use in thermal processing of soft contact lenses.

• Does the SoftTherm Sol. have any specific sterility claims beyond its thermal processing function?

  No, the SoftTherm Sol. does not make any explicit sterility claims beyond its role in applying controlled heat for sterilization and conditioning of soft contact lenses. Its efficacy relies on proper thermal processing rather than inherent sterility of the device itself.

• How should the SoftTherm Sol. be stored to maintain its intended performance?

  While the documentation does not specify exact storage conditions, the SoftTherm Sol. requires proper storage and handling to maintain its efficacy. Since it is reusable, it should be cleaned and stored in a clean, dry environment to prevent contamination and ensure reliable thermal processing for contact lens sterilization.