← Product Code [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) · K952261

# HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% (K952261)

_Pilkington Barnes-Hind, Ltd. · LPL · Jul 5, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K952261

## Device Facts

- **Applicant:** Pilkington Barnes-Hind, Ltd.
- **Product Code:** [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL.md)
- **Decision Date:** Jul 5, 1995
- **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/K952261](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K952261)

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