Cleared Traditional

K142830 - Ophthalmed Bending Laser Probes

K142830 is the FDA 510(k) clearance for Ophthalmed Bending Laser Probes by Ophthalmed, LLC. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K142830 · Ophthalmed, LLC · Ophthalmic device
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Jun 2015
Decision
268d
Days
Class 2
Risk

K142830 is an FDA 510(k) clearance for the Ophthalmed Bending Laser Probes. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ophthalmed, LLC (Roswell, US). The FDA issued a Cleared decision on June 25, 2015 after a review of 268 days - an extended review cycle.

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 Ophthalmed, LLC devices

Submission Details

510(k) Number K142830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date June 25, 2015
Days to Decision 268 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
158d slower than avg
Panel avg: 110d · This submission: 268d
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.

Regulatory Peers - HQF Laser, Ophthalmic

All 64
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