← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NUU — Lens, Contact, Orthokeratology, Overnight

Temporary reduction of myopia or refractive error.

DEVICE CLASS
Class III
REGULATION
21 CFR 886.5916
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P040029Euclid Vision Corporation · pma2026-04-02
P240045Contamac, Ltd. · pma2026-02-10
P010062Bausch & Lomb · pma2025-12-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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