Cleared Traditional

K071183 - ALLEGRO OCULYZER

K071183 is an FDA 510(k) clearance for ALLEGRO OCULYZER, manufactured by Wavelight AG. The device is a Class 2 Ophthalmic device with product code MXK cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K071183 · Wavelight AG · Ophthalmic device
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Jul 2007
Decision
81d
Days
Class 2
Risk

K071183 is an FDA 510(k) clearance for the ALLEGRO OCULYZER. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Wavelight AG (Erlangen, DE). The FDA issued a Cleared decision on July 20, 2007 after a review of 81 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.

View all Wavelight AG devices

FDA 510(k) Submission Details - K071183

510(k) Number K071183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date July 20, 2007
Days to Decision 81 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 110d · This submission: 81d
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 11
Devices cleared under the same product code (MXK) and FDA review panel - the closest regulatory comparables to K071183.
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ORBSCAN
K984443 · Technolas Perfect Vision GmbH · Mar 1999