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510(k) K801418

KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT by Keeler Optical Products , Ltd. — Product Code HPS

K801418 is an FDA 510(k) premarket notification submitted by Keeler Optical Products , Ltd. for the device "KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code HPS (Unit, Cryophthalmic), a Class II device regulated under 21 CFR 886.4170. Keeler Optical Products , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
June 17, 1980
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 Optical Products , Ltd.

  • K810403 — KEELER/KONAN SPECULAR MICROSCOPE (May 13, 1981)
  • K792255 — NEVYAS AUTOPRESS EYE COMPRESSOR (December 11, 1979)
  • K782141 — LEVIGATOR, KEELER PHOKO (January 26, 1979)
  • K781892 — LOCATOR, FOREIGN BODY (December 4, 1978)

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)
  • K833747 — GALLIE CRYONUCLEATOR (May 9, 1984)
  • K781338 — BEAVER CATARACT CYROXTRACTOR (February 12, 1979)
  • K790102 — MODEL 556-01 CRYOEXTRACTOR (February 12, 1979)

FDA data resources