← Product Code [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) · K010218

# VISTAKON (HEFILCON C) CONTACT LENSES (K010218)

_Vistakon · LPL · Mar 16, 2001 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K010218

## Device Facts

- **Applicant:** Vistakon
- **Product Code:** [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL.md)
- **Decision Date:** Mar 16, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5925
- **Device Class:** Class 2
- **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/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K010218](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K010218)

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