Objective Refractor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802029 ↗

FDA Product Code

HKO

Device Class

Class I

Regulation

21 CFR Part 886.1760

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Ophthalmic a/B Scan System, Model 835 -- Modified

  Class II

  FDA 510(k) K923348 Active Cleared 10 Dec 1992

• Humphrey Field Analyzer Model 630

  Class I

  FDA 510(k) K852639 Active Cleared 18 Sep 1985

• Humphrey Image Analyzer Model 110

  Class II

  FDA 510(k) K852638 Active Cleared 12 Aug 1985

• Zeiss Opmilas 144 Surgical Lasers

  Class II

  FDA 510(k) K942439 Active Cleared 1 Jul 1994

• Autokeratometer, Instrument

  Class I

  FDA 510(k) K781994 Active Cleared 12 Feb 1979

• Digital Ophthalmic Ultrasound Biomicroscope

  Class II

  FDA 510(k) K923211 Active Cleared 8 Nov 1993

See all devices from Zeiss Humphrey System →