Cleared Traditional

K063297 - LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR

K063297 is an FDA 510(k) clearance for LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR, manufactured by Lightmed Corp.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K063297 · Lightmed Corp. · Ophthalmic device
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Sep 2007
Decision
323d
Days
Class 2
Risk

K063297 is an FDA 510(k) clearance for the LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lightmed Corp. (Ben Lomond, US). The FDA issued a Cleared decision on September 20, 2007 after a review of 323 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Lightmed Corp. devices

FDA 510(k) Submission Details - K063297

510(k) Number K063297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date September 20, 2007
Days to Decision 323 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 110d · This submission: 323d
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.

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All 100
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