Who is the manufacturer of POLYMACON?

CooperVision, Inc. submitted the Traditional clearance for POLYMACON (K001089).

What is the FDA product code for POLYMACON?

LPL. It is classified under 21 CFR 886.5925 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for POLYMACON?

510(k) clearance (submission type: Traditional).

POLYMACON

K001089 · CooperVision, Inc. · LPL · May 19, 2000 · Ophthalmic

Device Facts

Record ID	K001089
Device Name	POLYMACON
Applicant	CooperVision, Inc.
Product Code	LPL · Ophthalmic
Decision Date	May 19, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.5925
Device Class	Class 2

Regulatory Classification

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.