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510(k) K842197

AMERICAN MEDICAL OPTICS I/A KIT- IRRIG by American Medical Optics — Product Code HQE

K842197 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMERICAN MEDICAL OPTICS I/A KIT- IRRIG". The FDA issued a decision of Substantially Equivalent on Oct 1, 1984. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. American Medical Optics has 16 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 1, 1984
Date Received
Jun 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type
510(k)

Other clearances by American Medical Optics

  • K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET (Feb 4, 1986)
  • K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS (May 1, 1985)
  • K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP (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)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (Sep 7, 1984)
  • K842251 — AMERI. MEDICAL OPTICS ARGON LASER PHOTO (Aug 15, 1984)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (Aug 10, 2022)
  • K170183 — Cetus system, Cetus probe (Sep 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (Apr 29, 2016)
  • K141065 — CONSTELLATION VISION SYSTEM (Aug 22, 2014)
  • K121675 — VERSAVIT (Jun 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (Apr 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (Nov 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (Jun 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (Apr 17, 2003)

FDA data resources

Source: FDA 510(k) database entry for K842197. Report a data issue: hello@regdatalab.com.