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510(k) K162783

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2016
Date Received
October 3, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tomography, Optical Coherence
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Bioptigen, Inc.

  • K150722 — EnFocus 2300, EnFocus 4400 (December 2, 2015)
  • K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) (May 11, 2012)
  • K063343 — BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (December 13, 2006)

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