Cleared Traditional

K111643 - OPTO MITRA YELLOW LASER

K111643 is an FDA 510(k) clearance for OPTO MITRA YELLOW LASER, manufactured by Opto Electronica SA. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K111643 · Opto Electronica SA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
143d
Days
Class 2
Risk

K111643 is an FDA 510(k) clearance for the OPTO MITRA YELLOW LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Opto Electronica SA (Sao Carlos, Sao Paulo, BR). The FDA issued a Cleared decision on November 3, 2011 after a review of 143 days - within the typical 510(k) review window.

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: 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 Opto Electronica SA devices

FDA 510(k) Submission Details - K111643

510(k) Number K111643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date November 03, 2011
Days to Decision 143 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
33d slower than avg
Panel avg: 110d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HQF Laser, Ophthalmic

All 108
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