Home / 510(k) Clearances / K874555

510(k) K874555

KEELER ACU 22XT OPHTHALMIC CRYO UNIT by Keeler Instruments, Inc. — Product Code HPS

K874555 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER ACU 22XT OPHTHALMIC CRYO UNIT". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code HPS (Unit, Cryophthalmic), a Class II device regulated under 21 CFR 886.4170. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1988
Date Received
November 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

Other clearances by Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

Other clearances for product code HPS

  • K202038 — CryoTreQ (December 30, 2020)
  • K940373 — OPHTHALMIC CRYO UNIT (July 18, 1994)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (October 11, 1990)
  • K873388 — KEELER CTU CRYO SYSTEM (November 13, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K833747 — GALLIE CRYONUCLEATOR (May 9, 1984)
  • K801418 — KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT (July 21, 1980)
  • K781338 — BEAVER CATARACT CYROXTRACTOR (February 12, 1979)
  • K790102 — MODEL 556-01 CRYOEXTRACTOR (February 12, 1979)

FDA data resources