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510(k) K860001

BARRAQUER-KRUMEICH REFRACTIVE SET by American Medical Optics — Product Code HNO

K860001 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "BARRAQUER-KRUMEICH REFRACTIVE SET". The FDA issued a decision of Substantially Equivalent on Feb 4, 1986. The device falls under product code HNO (Keratome, Ac-Powered), a Class I device regulated under 21 CFR 886.4370. American Medical Optics has 16 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 4, 1986
Date Received
Jan 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type
510(k)

Other clearances by American Medical Optics

  • K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (May 1, 1985)
  • K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (May 1, 1985)
  • K851262 — AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA (Apr 30, 1985)
  • K844150 — MEDICAL OPTICS PHACOEMULSIFICATION KIT (Dec 11, 1984)
  • K843966 — ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS (Nov 8, 1984)
  • K843965 — ARGON LASER PHOTOCOAGULATOR SYS (Nov 6, 1984)
  • K842504 — AMER. MEDICAL OPTICS DIGITAL KERATO- (Oct 1, 1984)
  • K842197 — AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (Oct 1, 1984)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (Sep 7, 1984)
  • K842251 — AMERI. MEDICAL OPTICS ARGON LASER PHOTO (Aug 15, 1984)

Other clearances for product code HNO

  • K173371 — VisuMax Femtosecond Laser (Apr 13, 2018)
  • K172994 — EPI K Console (Oct 26, 2017)
  • K072102 — EPIVISION SL SYSTEM (Jan 16, 2009)
  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (Aug 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (Sep 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (Mar 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (Jul 6, 2005)
  • K043183 — EPI-K (Mar 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (Jan 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (Nov 16, 2004)

FDA data resources

Source: FDA 510(k) database entry for K860001. Report a data issue: hello@regdatalab.com.