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Maxsight Polymacon Sport-Tinted Contact Lens

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050157

by Bausch & Lomb, Inc.

Identifiers

510(k) Number
K050157 FDA 510(k)
FDA Product Code
LPL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5925 FDA 510(k)
Regulation Number
886.5925 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Maxsight Polymacon Sport-Tinted Contact Lens is a hemispherical, flexible soft contact lens composed of polymacon, a HEMA and EGDMA polymer with 38.6% water content. It features a sport-specific tint using FDA-conforming dyes designed to enhance contrast and visual clarity in outdoor athletic settings.

This device is a daily wear soft contact lens that may be disinfected using a chemical disinfection system. It is classified as a Class II medical device under product code LPL and has received FDA 510(k) clearance.

Frequently asked questions

What is the primary purpose of the Maxsight contact lens?

This device is a sport-tinted soft contact lens designed to improve visual clarity and contrast for individuals participating in outdoor athletic activities.

What material is used to manufacture this lens?

The lens is composed of polymacon, which is a polymer made from HEMA and EGDMA. It features a water content of 38.6% to provide a flexible, hemispherical fit.

Is this lens intended for daily or extended wear?

The Maxsight lens is indicated for daily wear. It is compatible with chemical disinfection systems to maintain hygiene between uses.

What is the regulatory status of this device?

The Maxsight Polymacon Sport-Tinted Contact Lens is classified as a Class II medical device under product code LPL and has received FDA 510(k) clearance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS (K050157) — FDA 510(k ..., K050157 FDA 510(k) - MAXSIGHT (POLYMACON) SPORT-TINTED CONTA..., Maxsight (Polymacon) Sport-tinted Contact Lens, MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bausch & Lomb, Inc.

Sources (1)

  • FDA 510(k) K050157 24 fields · synced Sep 27, 2026