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510(k) K833747

GALLIE CRYONUCLEATOR by Mono Research Laboratories — Product Code HPS

K833747 is an FDA 510(k) premarket notification submitted by Mono Research Laboratories for the device "GALLIE CRYONUCLEATOR". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code HPS (Unit, Cryophthalmic), a Class II device regulated under 21 CFR 886.4170.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
October 26, 1983
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 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)
  • K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNIT (January 29, 1988)
  • K873388 — KEELER CTU CRYO SYSTEM (November 13, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • 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