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510(k) K162783

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

K162783 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 9, 2016. The device falls under product code OBO (Tomography, Optical Coherence), 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 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)

Other clearances for product code OBO

  • K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (May 7, 2026)
  • K252633 — UNITY DX (UDX) (December 23, 2025)
  • K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
  • K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
  • K240924 — Anterion (December 13, 2024)
  • K241163 — SPECTRALIS with Flex Module (October 11, 2024)
  • K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
  • K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
  • K233933 — CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
  • K233602 — P200TE (A10700) (May 9, 2024)

FDA data resources