What is FDA product code NUU?

Temporary reduction of myopia or refractive error.

Ophthalmic › TherapeuticLens, Contact, Orthokeratology, Overnight

Paragon CRT100

Name: Paragon CRT100
Brand: Paragon CRT100

Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three…

Registry build 21.09.26

Paragon CRT® 100 Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”. The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces. Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The material is thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, and green tints. The tinted lenses depending on the tint color contain D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.

1manufacturer

1catalogue number

2recalls on this code

Who Else Makes It

Registered in Tianjin.

Chinese manufacturers registered for FDA product code NUU
Manufacturer	City	Province	Registered as	Device types
Tianjin Mastervision Technology Co., Ltd.	Wuqing District	Tianjin	Manufacturer	2

Record

Regulatory record for Paragon CRT100
Listed by	Paragon Vision Sciences, Inc., United States
FDA product code	NUU
Device type	Lens, Contact, Orthokeratology, Overnight
Device class	Class 3
Regulation	21 CFR 886.5916
Establishment	Complaint-file establishment, Manufacturer
Record published	2021-04-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Paragon CRT100
Catalogue number	Size	Status
Paragon CRT 100		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	50
Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	8
Paragon CRT	Paragon Vision Sciences, Inc.	1
Paragon Z CRT	Paragon Vision Sciences, Inc.	1
Acuvue Abiliti Overnight Therapeutic lenses for myopia management	Menicon Co., Ltd.	1
Acuvue Abiliti overnight for myopia management with astigmatism	Menicon Co., Ltd.	1
Paragon RG-4	Paragon Vision Sciences, Inc.	1
Paragon CRT Dual Axis	Paragon Vision Sciences, Inc.	1
Paragon Z CRT Dual Axis	Paragon Vision Sciences, Inc.	1

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-06-26	Class II	Process control	Manufactured lenses are not covered by existing FDA approval	18,820 lenses
2023-06-26	Class II	Process control	Manufactured lenses are not covered by existing FDA approval	83,542 lenses

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P220015	2026-08-05	DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens	Tianjin Mastervision Technology Co., Ltd.
P240045	2026-02-10	Optimum Infinite (tisilfocon A) Orthokeratology Lenses II	Contamac Ltd.
P040029	2024-04-15	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact	Euclid Vision Corporation
P990018	2019-11-06	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear	Menicon Co., Ltd.
P010062	2014-07-28	BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS	Bausch & Lomb Incorporated
P050031	2006-11-16	PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY	CooperVision, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.