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Product Classification

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Device

lens, contact, for reading discomfort

Regulation Description

Soft (hydrophilic) contact lens.

Definition

This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

NIC

Premarket Review

Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)

Submission Type

510(k)

Regulation Number

886.5925

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Summary Malfunction
Reporting

Eligible

Implanted Device?

No

Life-Sustain/Support Device?

No

Recognized Consensus Standards

10-77 ISO 9394 Third edition 2012-10-01
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
10-85 ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
10-100 ISO 18259 First Edition 2014-10-01
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
10-101 ISO 18189 First edition 2016-06-01
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
10-106 ISO 18369-3 Second edition 2017-08
Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
10-107 ISO 18369-4 Second edition 2017-08
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials
10-108 ISO 18369-2 Third edition 2017-08
Ophthalmic optics - Contact lenses - Part 2: Tolerances
10-109 ISO 18369-1 Second edition 2017-08
Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications
10-111 ISO 11981 Third edition 2017-11
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
10-112 ISO 11986 Third edition 2017-11
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
10-139 ISO 11980 Fourth edition 2025-06
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
10-141 ISO 11978 Third edition 2017-08 [Including AMD1:2020]
Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)]

Third Party Review

Eligible for 510(k) Third Party Review Program

Accredited Persons

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