Cleared Traditional

K062624 - NEXT GENERATION LASER

K062624 is the FDA 510(k) clearance for NEXT GENERATION LASER by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K062624 · Alcon Laboratories · Ophthalmic device
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Nov 2007
Decision
426d
Days
Class 2
Risk

K062624 is an FDA 510(k) clearance for the NEXT GENERATION LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on November 5, 2007 after a review of 426 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 Alcon Laboratories devices

Submission Details

510(k) Number K062624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date November 05, 2007
Days to Decision 426 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 110d · This submission: 426d
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 63
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K062624.
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K051944 · Lumenis, Inc. · Sep 2005
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K033941 · Bausch & Lomb, Inc. · Feb 2004
DC-3300 LASER DIODE PHOTOCOAGULATOR
K013760 · Nidek, Inc. · Feb 2002