Cleared Traditional

K844358 - SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE S...

K844358 is the FDA 510(k) clearance for SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE S... by Coherent Medical Group. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K844358 · Coherent Medical Group · Ophthalmic device
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Jan 1985
Decision
55d
Days
Class 2
Risk

K844358 is an FDA 510(k) clearance for the SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP. 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 January 3, 1985 after a review of 55 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 Coherent Medical Group devices

Submission Details

510(k) Number K844358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date January 03, 1985
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 110d · This submission: 55d
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 K844358.
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K844668 · Cooper Lasersonics, Inc. · Jan 1985
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K840145 · Cooper Lasersonics, Inc. · Apr 1984