Cleared Abbreviated

K130195 - SCANNING LASERLINK

K130195 is an FDA 510(k) clearance for SCANNING LASERLINK, manufactured by Lumenis, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Abbreviated 510(k) pathway after a 277-day FDA review.

K130195 · Lumenis, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Nov 2013
Decision
277d
Days
Class 2
Risk

K130195 is an FDA 510(k) clearance for the SCANNING LASERLINK. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lumenis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 1, 2013 after a review of 277 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Lumenis, Inc. devices

FDA 510(k) Submission Details - K130195

510(k) Number K130195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2013
Decision Date November 01, 2013
Days to Decision 277 days
Submission Type Abbreviated
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
167d slower than avg
Panel avg: 110d · This submission: 277d
Pathway characteristics
Standards-based clearance path.

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 Consultant

Boston Scientific
Donna M Gardner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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