← Product Code [LPN](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN) · N18143

# PREFLEX AND FLEXCARE SOL. (N18143)

_Alcon Laboratories · LPN · Apr 26, 1982 · Ophthalmic · APWD_

**Canonical URL:** https://fda.innolitics.com/submissions/OPHTHALMIC/subpart-f%E2%80%94therapeutic-devices/LPN/N18143

## Device Facts

- **Applicant:** Alcon Laboratories
- **Product Code:** [LPN](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPN.md)
- **Decision Date:** Apr 26, 1982
- **Decision:** APWD
- **Regulation:** 21 CFR 886.5928
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

## Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

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**Source:** [https://fda.innolitics.com/submissions/OPHTHALMIC/subpart-f%E2%80%94therapeutic-devices/LPN/N18143](https://fda.innolitics.com/submissions/OPHTHALMIC/subpart-f%E2%80%94therapeutic-devices/LPN/N18143)

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