Keeler Acu 22XT Ophthalmic Cryo Unit

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

510(k) Number

K874555 ↗

FDA Product Code

HPS

Device Class

Class II

Regulation

21 CFR Part 886.4170

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Henson Cfa 3000 Central Visual Field Screener

  Class I

  FDA 510(k) K891610 Active Cleared 5 Jun 1989

• Keeler Tearscope-Plus

  Class II

  FDA 510(k) K973064 Active Cleared 7 Apr 1998

• Panoramic Loupes - Various

  Class II

  FDA 510(k) K841293 Active Cleared 9 May 1984

• Vickers Ergomatic Micros Instr-Long R or L Handed

  Class I

  FDA 510(k) K853180 Active Cleared 28 Oct 1985

• Henson - Hamblin Cfs 2000 Central Field Screen

  Class I

  FDA 510(k) K864467 Active Cleared 15 Dec 1986

• Spectacle Indirect Ophthalmoscope

  Class II

  FDA 510(k) K841292 Active Cleared 9 May 1984

See all devices from Keeler Instruments, Inc. →

• What is the Keeler Acu 22xt Ophthalmic Cryo Unit used for?

  The Keeler Acu 22xt Ophthalmic Cryo Unit is designed for use in ophthalmic surgical procedures involving cryotherapy, specifically for the application of extreme cold to ocular tissues as indicated by its classification and nomenclature within the ophthalmic specialty.

• Is the Keeler Acu 22xt Ophthalmic Cryo Unit reusable or single-use?

  The Keeler Acu 22xt Ophthalmic Cryo Unit is supplied as a reusable device, meaning it is intended for multiple uses after appropriate cleaning and reprocessing between procedures, as stated in the device description.

• What regulatory clearance does the Keeler Acu 22xt Ophthalmic Cryo Unit have?

  The Keeler Acu 22xt Ophthalmic Cryo Unit has FDA 510(k) clearance under submission number K874555, which was granted on January 29, 1988, and it is classified as a Class II medical device under regulation 886.4170 with product code HPS.