Cleared Traditional

K051944 - FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES

K051944 is an FDA 510(k) clearance for FAMILY OF SELECTA OPHTHALMIC LASER SYST..., manufactured by Lumenis, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K051944 · Lumenis, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
74d
Days
Class 2
Risk

K051944 is an FDA 510(k) clearance for the FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECT.... Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Lumenis, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 30, 2005 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lumenis, Inc. devices

FDA 510(k) Submission Details - K051944

510(k) Number K051944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2005
Decision Date September 30, 2005
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
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.

Regulatory Peers - HQF Laser, Ophthalmic

All 153
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K051944.
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K070776 · Quantel Medical · Apr 2007
IRIDEX WIRELESS FOOTSWITCH
K062074 · Iridex Corp · Nov 2006
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
K061024 · Peregrine Surgical , Ltd. · Jun 2006
20G SMA LASER FIBER, MODEL LF100
K050807 · Ophthalmed, LLC · Sep 2005
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
K050541 · Omniguide Communications, Inc. · May 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
K043613 · Quantel Medical · Mar 2005