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510(k) K851264

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS by American Medical Optics — Product Code HLI

K851264 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. American Medical Optics has 16 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
Mar 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type
510(k) Exempt

Other clearances by American Medical Optics

  • K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET (Feb 4, 1986)
  • 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)
  • 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 HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (Feb 11, 2016)
  • K150722 — EnFocus 2300, EnFocus 4400 (Dec 2, 2015)
  • K142953 — OCT-Camera (Mar 4, 2015)
  • K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE (Sep 17, 2014)
  • K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT (Apr 23, 2014)
  • K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES (Mar 26, 2014)
  • K133892 — IVUE 500 (Mar 19, 2014)
  • K123316 — HEINE OMEGA 500 (Feb 26, 2013)
  • K121739 — IVUE WITH NORMATIVE DATABASE (Jan 18, 2013)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)

FDA data resources

Source: FDA 510(k) database entry for K851264. Report a data issue: hello@regdatalab.com.