Cleared Traditional

SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)

K113129 · Heidelberg Engineering GmbH · Ophthalmic

Nov 2011

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K113129 is an FDA 510(k) clearance for the SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM), a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Heidelberg Engineering GmbH (Heidelberg, DE). The FDA issued a Cleared decision on November 8, 2011, 15 days after receiving the submission on October 24, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K113129 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2011
Decision Date	November 08, 2011
Days to Decision	15 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.