Cleared Traditional

K905141 - CENTAURI

K905141 is the FDA 510(k) clearance for CENTAURI by Pfizer Laser Systems. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K905141 · Pfizer Laser Systems · Ophthalmic device
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Feb 1991
Decision
88d
Days
Class 2
Risk

K905141 is an FDA 510(k) clearance for the CENTAURI. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Pfizer Laser Systems (Irvine, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 88 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 Pfizer Laser Systems devices

Submission Details

510(k) Number K905141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date February 11, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
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 65
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K905141.
NIDEK MODEL AC-2300
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ND:YAG LASER SYSTEMS (VARIOUS MODELS)
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CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · Candela Laser Corp. · Mar 1991
MICROLASE BY LASER TRABECULOPLASTY
K895213 · Keeler Instruments, Inc. · Oct 1989
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
K895196 · Nidek, Inc. · Oct 1989
NIDEK MODEL AKC-8000
K894273 · Nidek, Inc. · Aug 1989