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Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240618

by Acuity Polymers, Inc.

Identifiers

510(k) Number
K240618 FDA 510(k)
FDA Product Code
HQD FDA 510(k)
Models / Variants
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens FDA 510(k)
Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens FDA 510(k)
Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens FDA 510(k)
Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5916 FDA 510(k)
Regulation Number
886.5916 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more models by Acuity Polymers, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acuity Polymers, Inc.

Sources (1)

  • FDA 510(k) K240618 24 fields · synced Jun 18, 2026