Lens, Contact, Orthokeratology, Overnight

Who Makes This Device Type in China?

The one Chinese manufacturer registered for this device type is based in Tianjin.

Tianjin Mastervision Technology Co., Ltd. Tianjin

What Is It?

Temporary reduction of myopia or refractive error.

How Is NUU Classified?

Lens, Contact, Orthokeratology, Overnight is FDA product code NUU, Class 3, 21 CFR 886.5916.

How Does It Reach the US Market?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. 1 approval under this code is held by a Chinese applicant.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2023. None was by a company in China. The root cause the FDA records most often is Process control (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Lens, Contact, Orthokeratology, Overnight

Paragon Z CRT Dual Axis

Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three…

Lens, Contact, Orthokeratology, Overnight

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…

Lens, Contact, Orthokeratology, Overnight

Paragon CRT Dual Axis

Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon CRT Dual Axis® Contact Lenses are manufactured from Paragon HDS®…

Lens, Contact, Orthokeratology, Overnight

Paragon RG-4

Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an…

Lens, Contact, Orthokeratology, Overnight

Acuvue Abiliti Overnight for Myopia Management With Astigmatism

Catalogue number ACUVUE Abiliti, listed by Menicon Co., Ltd., Japan, under Lens, Contact, Orthokeratology, Overnight. 1 manufacturer in China is registered for this product code.

Lens, Contact, Orthokeratology, Overnight

Acuvue Abiliti Overnight Therapeutic Lenses for Myopia Management

Catalogue number ACUVUE Abiliti, listed by Menicon Co., Ltd., Japan, under Lens, Contact, Orthokeratology, Overnight. 1 manufacturer in China is registered for this product code.

Lens, Contact, Orthokeratology, Overnight

Paragon Z CRT

Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: The…

Lens, Contact, Orthokeratology, Overnight

Paragon CRT

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

Lens, Contact, Orthokeratology, Overnight

Euclid Orthokeratology (Oprifocon A) Contact Lenses for Overnight Wear

Kit containing 1x 00850007135065 (Emerald Toric, oprifocon A, Green) China Distribution; Alternate Trials: Emerald Toric Trial, Emerald Advance Toric Trial, Emerald Toric Essential Toric…

Lens, Contact, Orthokeratology, Overnight

Euclid Orthokeratology (Tisilfocon A) Contact Lenses for Overnight Wear

Emerald MAX Toric, tisilfocon A, Green

Lens, Contact, Orthokeratology, Overnight

Who Makes This Device Type in China?

What Is It?

How Is NUU Classified?

How Does It Reach the US Market?

What Do the Recalls Say?

Where China Actually Supplies