Cleared Traditional

K133019 - FIBERION OPHTHALMIC ENDOLASER PROBE (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133019 · Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim · Ophthalmic device
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Feb 2015
Decision
512d
Days
Class 2
Risk

K133019 is an FDA 510(k) clearance for the FIBERION OPHTHALMIC ENDOLASER PROBE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim (Istanbul, TR). The FDA issued a Cleared decision on February 20, 2015 after a review of 512 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim devices

Submission Details

510(k) Number K133019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date February 20, 2015
Days to Decision 512 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
402d slower than avg
Panel avg: 110d · This submission: 512d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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.

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