UNISOL

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

Generic Name

Accessories, soft lens products

PMA Number

P790011 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S005

• Gentle Touch UV (Netrafilcon A) Soft Contact Lenses

  Class II

  FDA 510(k) K991000 Active Cleared 28 Jun 1999

• Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical ( Hydrophilic)C

  Class II

  FDA 510(k) K000439 Active Cleared 20 Mar 2000

• Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K994335 Active Cleared 20 Mar 2000

• Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi

  Class II

  FDA 510(k) K993935 Active Cleared 21 Dec 1999

• Precision UV (Vasurfilcon a)

  Class II

  FDA 510(k) K982988 Active Cleared 6 Jan 1999

• Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite Tint

  Class II

  FDA 510(k) K954603 Active Cleared 4 Jan 1996

See all devices from Wesley Jessen Corp. →

• What is the UNISOL device used for?

  UNISOL is a soft lens product accessory intended for ophthalmic use. It is classified under the generic name 'Accessories, soft lens products' and is manufactured by Wesley Jessen Corp.

• Is the UNISOL device sterile?

  The device data does not provide information regarding the sterility status of UNISOL. No details about sterility are included in the provided information.

• Can the UNISOL device be reused or is it single-use?

  The device data does not specify whether UNISOL is designed for single-use or reusable purposes. No information about its reuse status is provided in the available data.

• What are the available sizes or models of UNISOL?

  The device data does not include information about the available sizes or models of UNISOL. No details regarding variations or specifications are provided.

• What are the storage conditions for UNISOL?

  The device data does not provide information about the storage conditions for UNISOL. No details regarding temperature, humidity, or other storage requirements are included in the available data.