510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NUUClass III

Lens, Contact, Orthokeratology, Overnight

21 CFR 886.5916 / Ophthalmic
FDA source (opens on fda.gov)

NUU is the FDA product code for Lens, Contact, Orthokeratology, Overnight, a class III device type, regulated under 21 CFR 886.5916. FDA's definition for this code reads: "Temporary reduction of myopia or refractive error". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
NUU
Device name
Lens, Contact, Orthokeratology, Overnight
FDA definition
Temporary reduction of myopia or refractive error.
Regulation
21 CFR 886.5916
Device class
Class III
Review panel
Ophthalmic
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order