Lens, Contact (orthokeratology)

Device Code: 4358

Product Code(s): MUW

Device Classification Information

Device Type ID	4358
Device Name	Lens, Contact (orthokeratology)
Regulation Description	Rigid Gas Permeable Contact Lens.
Regulation Medical Specialty	Ophthalmic
Review Panel	Ophthalmic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD)
Submission Type	510(k)
CFR Regulation Number	886.5916 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	MUW
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

10-60 ISO 11981 Second Edition 2009-07-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses
10-67 ISO 11986 Second Edition 2010-11-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Guidelines For Determination Of Preservation Uptake And Release
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

Total Product Life Cycle

Device Type ID	4358
Device	Lens, Contact (orthokeratology)
Product Code	MUW
FDA Device Classification	Class 2 Medical Device
Regulation Description	Rigid Gas Permeable Contact Lens.
CFR Regulation Number	886.5916 [🔎]

Premarket Reviews
Manufacturer	Decision
CONTAMAC LTD.
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 20:47:34