Ocuplot D

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

Full name

The Ocuplot D

510(k) Number

K822415 ↗

FDA Product Code

HPJ

Device Class

Class II

Regulation

21 CFR Part 886.1360

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Accessories for Sys. 400 CO2 Surg. Laser

  Class II

  FDA 510(k) K791895 Active Cleared 20 Dec 1979

• Model 900K Photocoagulator

  Class II

  FDA 510(k) K801336 Active Cleared 28 Jul 1980

• Dioptron III Autorefractor

  Class I

  FDA 510(k) K801906 Active Cleared 27 Aug 1980

• Coherent Fundusl Retinal Camera

  Class II

  FDA 510(k) K822908 Active Cleared 5 Jan 1983

• Coherent Holmium:yag Surgical Laser

  Class II

  FDA 510(k) K902990 Active Cleared 2 Oct 1990

• Neodymium: Yag Ophthalmic Laser System 9900

  Class III

  FDA PMA P830054 Active Approved 2 Jul 1984

• What is the primary function of the Ocuplot D?

  The Ocuplot D is a diagnostic laser instrument specifically designed for ophthalmic applications. Its primary function is to assess and measure visual field parameters in a clinical setting.

• What is the regulatory classification of this device?

  The Ocuplot D is classified as a class 2 medical device under regulation number 886.1360. It received FDA 510(k) clearance under reference number K822415, confirming it is substantially equivalent to other legally marketed devices.

• Which medical specialty is this instrument intended for?

  This device is intended for use within the ophthalmic specialty. It is categorized under the Ophthalmic advisory committee and is designed to assist clinicians in evaluating visual field performance.