Cleared Traditional

K050541 - OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY

K050541 is an FDA 510(k) clearance for OMNIGUIDE BEAMPATH CO2 MARK I LASER BEA..., manufactured by Omniguide Communications, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K050541 · Omniguide Communications, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
68d
Days
Class 2
Risk

K050541 is an FDA 510(k) clearance for the OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Omniguide Communications, Inc. (Cambridge, US). The FDA issued a Cleared decision on May 9, 2005 after a review of 68 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 Omniguide Communications, Inc. devices

FDA 510(k) Submission Details - K050541

510(k) Number K050541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date May 09, 2005
Days to Decision 68 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
42d faster than avg
Panel avg: 110d · This submission: 68d
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 124
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K050541.
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR
K070776 · Quantel Medical · Apr 2007
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60
K061024 · Peregrine Surgical , Ltd. · Jun 2006
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
K051944 · Lumenis, Inc. · Sep 2005
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II
K043613 · Quantel Medical · Mar 2005
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA
K043236 · Quantel Medical · Feb 2005
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · Bausch & Lomb, Inc. · Feb 2004