Cleared Traditional

K030719 - PENTACAM SCHEIMPFLUG CAMERA

K030719 is an FDA 510(k) clearance for PENTACAM SCHEIMPFLUG CAMERA, manufactured by Oculus Optikgerate GmbH. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K030719 · Oculus Optikgerate GmbH · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
193d
Days
Class 2
Risk

K030719 is an FDA 510(k) clearance for the PENTACAM SCHEIMPFLUG CAMERA. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Oculus Optikgerate GmbH (Woodinville, US). The FDA issued a Cleared decision on September 16, 2003 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K030719

510(k) Number K030719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2003
Decision Date September 16, 2003
Days to Decision 193 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K030719.
PATHFINDER
K031788 · Massie Research Laboratories, Inc. · Sep 2004
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)
K040913 · Bausch & Lomb · Jul 2004
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · Haag-Streit Holding AG · Sep 2003
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · Nidek, Inc. · Aug 1999
ORBSCAN
K984443 · Technolas Perfect Vision GmbH · Mar 1999
K030719 · PENTACAM SCHEIMPFLUG CAMERA
Download PDF FDA Summary Oculus Optikgerate Gm…