Cleared Traditional

SYSTEM 930 ARGON PHOTOCOAGULATOR (K844356) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844356 · Coherent Medical Group · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
188d
Days
Class 2
Risk

K844356 is an FDA 510(k) clearance for the SYSTEM 930 ARGON PHOTOCOAGULATOR. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Coherent Medical Group (Palo Alto, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 188 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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 K844356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date May 16, 1985
Days to Decision 188 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 110d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 29
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K844356.
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
K220263 · Vortex Surgical, Inc. · Nov 2022
MAXReach Laser Probe
K191846 · Vortex Surgical, Inc. · Dec 2019
Vitreq disposable laser probes, light fibers and Chandelier
K182646 · Vitreq BV · May 2019