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510(k) K150722

EnFocus 2300, EnFocus 4400 by Bioptigen, Inc. — Product Code HLI

K150722 is an FDA 510(k) premarket notification submitted by Bioptigen, Inc. for the device "EnFocus 2300, EnFocus 4400". The FDA issued a decision of Substantially Equivalent on December 2, 2015. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Bioptigen, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2015
Date Received
March 20, 2015
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 Bioptigen, Inc.

  • K162783 — EnFocus 2300, EnFocus 4400 (December 9, 2016)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)
  • K063343 — BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (December 13, 2006)

Other clearances for product code HLI

  • K153080 — RTVue XR OCT Avanti with AngioVue Software (February 11, 2016)
  • 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)
  • K120238 — RTVUE XR OCT (April 3, 2012)

FDA data resources