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Hydrocurve Patient Disinfection Unit

by Wesley Jessen Corp.

PMA N17367

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA N17367

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN17367 Date14 Nov 1984ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Sterilizer, soft-lens, thermal, ac-powered
PMA Number
FDA Product Code
HRD
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S011

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.

The Hydrocurve Patient Disinfection Unit is a thermal sterilizer designed for soft contact lenses. It uses AC power to disinfect and sterilize soft lenses, providing a hygienic solution for contact lens care.

This device is supplied as a single unit and is intended for patient use in ophthalmic settings. It is classified as a Class II medical device under FDA regulation 886.5928, with PMA number N17367, and is manufactured by Wesley Jessen Corp. in Des Plaines, IL.

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