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Acuity ON500-Uv-23.0

by Eyekon Medical Inc.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

PMA P880072

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM454ON500UVP2301 UDI-DI Date18 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP880072 Date22 Sep 1989DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 8 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Acuity
Generic name
Posterior-chamber intraocular lens, pseudophakic
Model / reference
ON500-UV-23.0
Primary DI / UDI-DI
M454ON500UVP2301
PMA number
FDA product code
HQL
GMDN term
Posterior-chamber intraocular lens, pseudophakic
Device class
Class III
Regulation number
886.3600
GUDID distribution status
In Commercial Distribution

Other devices from Eyekon Medical Inc.

See all devices from Eyekon Medical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (7)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No