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510(k) K882517

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE by Rodenstock Instrument Corp. — Product Code HLI

K882517 is an FDA 510(k) premarket notification submitted by Rodenstock Instrument Corp. for the device "RODENSTOCK SCANNING LASER OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Rodenstock Instrument Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
June 17, 1988
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 Rodenstock Instrument Corp.

  • K781440 — LENSOMETER MODEL 11 (September 7, 1978)

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