Cleared Traditional

SPECTRALIS with Flex Module

K241163 · Heidelberg Engineering GmbH · Ophthalmic

Oct 2024

Decision

168d

Days

Class 2

Risk

About This 510(k) Submission

K241163 is an FDA 510(k) clearance for the SPECTRALIS with Flex Module, 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 October 11, 2024, 168 days after receiving the submission on April 26, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K241163 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2024
Decision Date	October 11, 2024
Days to Decision	168 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.