Cleared Traditional

K050807 - 20G SMA LASER FIBER

K050807 is the FDA 510(k) clearance for 20G SMA LASER FIBER by Ophthalmed, LLC. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K050807 · Ophthalmed, LLC · Ophthalmic device
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Sep 2005
Decision
175d
Days
Class 2
Risk

K050807 is an FDA 510(k) clearance for the 20G SMA LASER FIBER, MODEL LF100. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Ophthalmed, LLC (Alpharetta, US). The FDA issued a Cleared decision on September 21, 2005 after a review of 175 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 K050807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2005
Decision Date September 21, 2005
Days to Decision 175 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
65d slower than avg
Panel avg: 110d · This submission: 175d
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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