OCT-Camera— 510(k) K142953

Substantially Equivalent

Optomedical Technologies GmbH

FDA 510(k) clearance K142953 for OCT-Camera, Substantially Equivalent on 2015-03-04. Applicant: Optomedical Technologies GmbH. Device class: 2.

Clearance details

Applicant: Optomedical Technologies GmbH
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2014-10-10
Decision date: 2015-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLI

K153080 — RTVue XR OCT Avanti with AngioVue Software2016-02-11
K150722 — EnFocus 2300, EnFocus 44002015-12-02
K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE2014-09-17
K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT2014-04-23
K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES2014-03-26

More clearances from Optomedical Technologies GmbH

K200516 — OCT-Camera ID 21101A32020-09-02

Recalls naming K142953

K-number listed on FDA's recall record

Z-0477-2022 — OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4Class II·Ongoing·Haag-Streit USA Inc·20211103
Z-0478-2022 — OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4Class II·Ongoing·Haag-Streit USA Inc·20211103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142953.

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