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Boston Orthokeratology Shaping Lens for Overnight Wear

FDA PMA

Class III (US FDA PMA)

PMA P010062

by Bausch and Lomb

Identity

Trade Name
EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR FDA PMA
Generic Name
Lens, contact, orthokeratology, overnight FDA PMA

Identifiers

PMA Number
P010062 FDA PMA
FDA Product Code
NUU FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.5916 FDA PMA
Regulation Number
886.5916 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA

This device is a contact lens designed for orthokeratology, classified as a Lens, Contact, Orthokeratology, Overnight. It reshapes the cornea to temporarily reduce myopic refractive error in non-diseased eyes, with an indication for overnight wear to correct myopia up to 5.00 diopters and astigmatism up to 1.50 diopters. Manufactured with oprifocon A material, it is intended for temporary correction without continuous lens wear.

The lenses are supplied as single-use, non-sterile items and must be disinfected using a chemical disinfection system only. They are regulated under FDA_PMA (PMA Number: P010062) and fall under Device Class 3 (Regulation Number: 886.5916). Compliance with prescribed overnight wear schedules is critical to maintain intended myopia reduction, as deviations may impact daily vision and correction stability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Bausch and Lomb
FDA Applicant
Bausch & Lomb

Sources (1)

  • FDA PMA P010062 24 fields · synced Oct 6, 2026