Cleared Traditional

SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT

K121993 · Heidelberg Engineering GmbH · Ophthalmic

Oct 2012

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K121993 is an FDA 510(k) clearance for the SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Heidelberg Engineering GmbH (Fairfax, US). The FDA issued a Cleared decision on October 25, 2012, 111 days after receiving the submission on July 6, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K121993 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2012
Decision Date	October 25, 2012
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.