Cleared Traditional

K133562 - CATARHEX 3

K133562 is an FDA 510(k) clearance for CATARHEX 3, manufactured by Oertli Instrumente AG. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K133562 · Oertli Instrumente AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
265d
Days
Class 2
Risk

K133562 is an FDA 510(k) clearance for the CATARHEX 3. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Oertli Instrumente AG (Berneck, CH). The FDA issued a Cleared decision on August 12, 2014 after a review of 265 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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.

View all Oertli Instrumente AG devices

FDA 510(k) Submission Details - K133562

510(k) Number K133562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date August 12, 2014
Days to Decision 265 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
155d slower than avg
Panel avg: 110d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 122
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