Cleared Traditional

K052935 - HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)

K052935 is an FDA 510(k) clearance for HEIDELBERG ENGINEERING SLITLAMP-OCT (SL..., manufactured by Heidelberg Engineering. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K052935 · Heidelberg Engineering · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
86d
Days
Class 2
Risk

K052935 is an FDA 510(k) clearance for the HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT). Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Heidelberg Engineering (Dossenheim, DE). The FDA issued a Cleared decision on January 13, 2006 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K052935

510(k) Number K052935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2005
Decision Date January 13, 2006
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MXK Device Classification - Class 2, Special Controls

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
JEFFREY D RONGERO

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MXK Device, Analysis, Anterior Segment

All 22
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K052935.
ARGOS
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ALLEGRO OCULYZER
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CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
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PACHYCAM
K041841 · Oculus Optikgerate GmbH · Jan 2005
HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
K042742 · Heidelberg Engineering · Oct 2004
K052935 · HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
Download PDF FDA Summary Heidelberg Engineering