NUU

Product Code: NUU

Products Classified as NUU

4390

Lens, Contact, Orthokeratology, Overnight

Rigid Gas Permeable Contact Lens.

Total Product Life Cycle (TPLC) Devices

4390

Lens, Contact, Orthokeratology, Overnight

Rigid Gas Permeable Contact Lens.

FDA Consensus Standards

• Lens, Contact, Orthokeratology, Overnight [37850]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [37852]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [37869]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [31258]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [38769]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [37075]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [38809]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [33619]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [34448]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [37081]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [37077]: 21 CFR §886.5916 🔎
• Lens, Contact, Orthokeratology, Overnight [37868]: 21 CFR §886.5916 🔎

Pre-market Approvals for NUU

P870024	PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..	PARAGON VISION SCIENCES
P010062	Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment	BAUSCH & LOMB
P050031	Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses	PARAGON VISION SCIENCES
P040029	Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear; Euclid Systems ORthokeratology (tisilfoc	Euclid Systems Corporation

Global Unique Device Identification Database

• 85000713500232: Lens, Contact, Orthokeratology, Overnight
• 85000713500225: Lens, Contact, Orthokeratology, Overnight
• 85000713500218: Lens, Contact, Orthokeratology, Overnight
• 85000713500195: Lens, Contact, Orthokeratology, Overnight
• 85000713500188: Lens, Contact, Orthokeratology, Overnight
• 85000713500171: Lens, Contact, Orthokeratology, Overnight
• 85000713500164: Lens, Contact, Orthokeratology, Overnight
• 85000713500157: Lens, Contact, Orthokeratology, Overnight
• 85000713500140: Lens, Contact, Orthokeratology, Overnight
• 85000713500133: Lens, Contact, Orthokeratology, Overnight
• 85000713500126: Lens, Contact, Orthokeratology, Overnight
• 85000713500119: Lens, Contact, Orthokeratology, Overnight
• 85000713500102: Lens, Contact, Orthokeratology, Overnight
• 85000713599984: Lens, Contact, Orthokeratology, Overnight
• 85000713599991: Lens, Contact, Orthokeratology, Overnight

Maude Adverse Events

EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR	EUCLID SYSTEMS CORPORATION	2020-01-10
PARAGON CRT100	PARAGON VISION SCIENCES,INC.	2019-10-02
EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR	EUCLID SYSTEMS CORPORATION	2019-09-20
EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR	EUCLID SYSTEMS CORPORATION	2019-08-15
ORTHOKERATOTIC CONTACT LENS	EUCLID SYSTEMS CORP	2019-07-31
PARAGON CRT100 CONTACT LENS	PARAGON VISION SCIENCES, INC	2019-07-31
ORTHOKERATOLOGY, CRT CONTACTS	UNK	2018-11-27
ORTHOKERATOLOGY, CRT CONTACTS	UNK	2018-11-27