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Oti-05 & Lathe-40 (Polymacon) Lathe-Cut Hydrophili

by Ocular Technologies, Inc.

PMA P890031

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P890031↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP890031 Date6 Mar 1991ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Lenses, soft contact, daily wear
PMA Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S001 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Lens, Soft Contact, Daily Wear, designed for ophthalmic use. It consists of lathe-cut, hydrophilic polymacon material, intended for corneal or scleral fitting to correct refractive errors or manage ocular surface conditions.

The OTI-05 and LATHE-40 lenses are supplied as single-use, non-sterile contact lenses, manufactured by Ocular Technologies, Inc. in Raleigh, North Carolina. They are classified as Class II devices under FDA regulations (21 CFR 886.5925) and were granted FDA_PMA approval (PMA Number: P890031). Storage and handling must comply with standard ophthalmic contact lens protocols.