EnFocus 2300, EnFocus 4400— 510(k) K150722

Substantially Equivalent

Bioptigen, Inc.

FDA 510(k) clearance K150722 for EnFocus 2300, EnFocus 4400, Substantially Equivalent on 2015-12-02. Applicant: Bioptigen, Inc.. Device class: 2.

Clearance details

Applicant: Bioptigen, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2015-03-20
Decision date: 2015-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Bioptigen, Inc.

K162783 — EnFocus 2300, EnFocus 44002016-12-09
K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)2012-05-11
K063343 — BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM2006-12-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.