← Product Code [LPM](/productcode/LPM) · P790020S042

# SAUFLON(R) PW (LIDOFILCON B) (P790020S042)

_Advanced Medical Optics, Inc. · LPM · Dec 16, 1988 · Ophthalmic · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P790020S042

## Device Facts

- **Applicant:** Advanced Medical Optics, Inc.
- **Product Code:** [LPM](/productcode/LPM.md)
- **Decision Date:** Dec 16, 1988
- **Decision:** APPR
- **Regulation:** 21 CFR 886.5925
- **Device Class:** Class 3
- **Review Panel:** Ophthalmic

## Regulatory Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

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**Source:** [https://fda.innolitics.com/device/P790020S042](https://fda.innolitics.com/device/P790020S042)

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