Cleared Traditional

K905453 - CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND

K905453 is an FDA 510(k) clearance for CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0...., manufactured by Douglas James Donaldson Compliance Services. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905453 · Douglas James Donaldson Compliance Services · Ophthalmic device
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Mar 1991
Decision
90d
Days
Class 2
Risk

K905453 is an FDA 510(k) clearance for the CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Douglas James Donaldson Compliance Services (Oakland, US). The FDA issued a Cleared decision on March 5, 1991 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K905453

510(k) Number K905453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date March 05, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 144
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K905453.
HGM ASPIRATING ENDOOCULAR(TM) PROBE
K925663 · Hgm, Inc. · Aug 1993
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K910805 · Heraeus Lasersonics, Inc. · May 1991
COMPAC(TM) DIODE LASERS
K904699 · Hgm Medical Laser Systems, Inc. · Apr 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · Candela Laser Corp. · Mar 1991
CENTAURI
K905141 · Pfizer Laser Systems · Feb 1991
MICROLASE BY LASER TRABECULOPLASTY
K895213 · Keeler Instruments, Inc. · Oct 1989