Cleared Traditional

K073508 - PARKONE

K073508 is an FDA 510(k) clearance for PARKONE, 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 273-day FDA review.

K073508 · Oculus Optikgerate GmbH · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
273d
Days
Class 2
Risk

K073508 is an FDA 510(k) clearance for the PARKONE. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Oculus Optikgerate GmbH (Wetzlar, DE). The FDA issued a Cleared decision on September 11, 2008 after a review of 273 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 - K073508

510(k) Number K073508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2007
Decision Date September 11, 2008
Days to Decision 273 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
163d slower than avg
Panel avg: 110d · This submission: 273d
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 K073508.
ARGOS
K191051 · Santec Corporation · May 2019
Pentacam AXL
K152311 · Oculus Optikgerate GmbH · Jan 2016
ARGOS
K150754 · Santec Corporation · Oct 2015
ALLEGRO OCULYZER
K071183 · Wavelight AG · Jul 2007
HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
K052935 · Heidelberg Engineering · Jan 2006
CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA
K051940 · Sis Ltd., Surgical Instrument Systems · Sep 2005
K073508 · PARKONE
Download PDF FDA Summary Oculus Optikgerate Gm…