Product code NUU

Device name: Lens, Contact, Orthokeratology, Overnight
Medical specialty: Ophthalmic
Device class: 3
Regulation number: 886.5916
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Temporary reduction of myopia or refractive error.
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P040029S026	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact	Euclid Vision Corporation	2026-04-02
P040029S025	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact	Euclid Vision Corporation	2026-03-12
P040029S021	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le	Euclid Vision Corporation	2026-03-06
P240045	Optimum Infinite (tisilfocon A) Orthokeratology Lenses II	Contamac, Ltd.	2026-02-10
P010062S015	Boston Orthokeratology (oprifocon A)	Bausch & Lomb	2025-12-16
P040029S023	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact	Euclid Vision Corporation	2025-05-23
P010062S014	Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment	Bausch & Lomb	2025-02-20
P040029S024	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le	Euclid Vision Corporation	2024-12-23
P010062S013	Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment	Bausch & Lomb	2024-07-18
P040029S022	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact	Euclid Vision Corporation	2024-04-15
P990018S009	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni	Menicon Co, Ltd.	2023-05-01
P990018S008	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni	Menicon Co, Ltd.	2022-08-02
P050031S009	Paragon Z CRT, Paragon Z CRT Dual Axis	CooperVision, Inc.	2022-05-10
P040029S020	Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil	Euclid Vision Corporation	2021-07-26
P990018S006	ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management	Menicon Co, Ltd.	2021-05-06
P040029S017	Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2021-03-30
P040029S019	Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil	Euclid Vision Corporation	2021-02-08
P040029S016	Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil	Euclid Vision Corporation	2021-02-04
P040029S015	Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2020-12-17
P050031S007	Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints	CooperVision, Inc.	2020-08-31
P050031S006	Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints	CooperVision, Inc.	2020-08-31
P040029S014	Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2020-08-24
P870024S053	Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin	CooperVision, Inc.	2020-04-20
P040029S012	Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil	Euclid Vision Corporation	2020-02-28
P050031S004	Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint	CooperVision, Inc.	2020-01-10
P990018S005	Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear	Menicon Co, Ltd.	2019-11-06
P040029S009	Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-10-24
P040029S006	Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco	Euclid Vision Corporation	2019-08-07
P040029S008	Euclid Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-18
P050031S005	Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint	CooperVision, Inc.	2019-07-11

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10840162000206	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
10840162000190	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
10840162000183	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
00850007135546	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
00850007135539	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
00850007135522	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
00850007135515	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2026-02-05
00192538901086	MeniconZ (tisilfocon A) Red	MENICON CO.,LTD.	2023-06-09
10850007135970	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2021-02-22
10850007135963	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2021-02-22
10850007135987	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2021-02-22
10850007135994	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2021-02-22
00865576000294	Optimum Infinite	CONTAMAC HOLDINGS LIMITED	2020-07-28
18500071350220	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2020-03-02
18500071350237	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2020-03-02
18500071350206	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2020-02-29
18500071350213	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2020-02-29
00850007135072	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135096	Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135089	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135065	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135058	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135041	Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135034	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135027	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135010	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
00850007135003	Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear	Euclid Vision Corporation	2019-07-19
B22209	Paragon HDS100	Paragon Vision Sciences, Inc.	2018-03-23
B22208	Paragon HDS	Paragon Vision Sciences, Inc.	2018-03-23
00785811435639	Boston Equalens II	Bausch & Lomb Incorporated	2017-10-18

Product code NUU

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