Cleared Traditional

K844357 - SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR

K844357 is the FDA 510(k) clearance for SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR by Coherent Medical Group. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K844357 · Coherent Medical Group · Ophthalmic device
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Jun 1985
Decision
208d
Days
Class 2
Risk

K844357 is an FDA 510(k) clearance for the SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Coherent Medical Group (Walker, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 208 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 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.

View all Coherent Medical Group devices

Submission Details

510(k) Number K844357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date June 05, 1985
Days to Decision 208 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 110d · This submission: 208d
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 K844357.
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · CooperVision, Inc. · Sep 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · CooperVision, Inc. · Feb 1986
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K852529 · Visitec Co. · Sep 1985
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K844668 · Cooper Lasersonics, Inc. · Jan 1985
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412 · Cooper Lasersonics, Inc. · Jun 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · Cooper Lasersonics, Inc. · Apr 1984