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510(k) K983999

PANORAMIC200 OPTHALMOSCOPE by Optos Plc. — Product Code HLI

K983999 is an FDA 510(k) premarket notification submitted by Optos Plc. for the device "PANORAMIC200 OPTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on February 3, 1999. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Optos Plc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1999
Date Received
November 9, 1998
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

Other clearances by Optos Plc.

  • K233602 — P200TE (A10700) (May 9, 2024)
  • K231673 — P200TE (A10700) (August 18, 2023)
  • K190732 — P200TxE (July 31, 2019)
  • K173707 — P200TE (February 28, 2018)
  • K162039 — OptosAdvance 4.0 Software (February 8, 2017)
  • K142897 — P200DTx (January 16, 2015)
  • K134039 — DAYTONA ICG (P200TICG) (April 11, 2014)
  • K121043 — OPTOS OCT/SLO MICROPERIMETER (February 22, 2013)
  • K113696 — OPTOS ADVANCE (May 25, 2012)
  • K111628 — P200T (August 19, 2011)

Other clearances for product code HLI

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

FDA data resources