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FDA PMA

Lens, contact, orthokeratology, overnight

PMA Number: P010062 · 2025-12-16

ApplicantBausch & Lomb
Decision Date2025-12-16
PMA NumberP010062
Product CodeNUU
Device ClassClass 3
Medical SpecialtyO
Regulation Number21 CFR 8
Advisory CommitteeOP

Device Summary

Lens, contact, orthokeratology, overnight is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb. It received FDA 510(k) clearance on 2025-12-16. The device is classified under product code NUU. It was reviewed by the OP advisory panel.

Frequently Asked Questions

What is the Lens, contact, orthokeratology, overnight?

Lens, contact, orthokeratology, overnight is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Bausch & Lomb.

When did Lens, contact, orthokeratology, overnight receive FDA 510(k) clearance?

The clearance date for Lens, contact, orthokeratology, overnight can be found in the official FDA records.

Who is the listed applicant for Lens, contact, orthokeratology, overnight?

The FDA 510(k) record lists Bausch & Lomb as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lens, contact, orthokeratology, overnight?

The FDA product code for Lens, contact, orthokeratology, overnight is NUU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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