Cleared Traditional

K844356 - SYSTEM 930 ARGON PHOTOCOAGULATOR

K844356 is an FDA 510(k) clearance for SYSTEM 930 ARGON PHOTOCOAGULATOR, manufactured by Coherent Medical Group. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K844356 · Coherent Medical Group · Ophthalmic device
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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

FDA 510(k) Submission Details - K844356

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
Combination Product No
PCCP Authorized No
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.

HQB Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K844356.
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441 · Surgical Laser Technologies, Inc. · Sep 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · Advanced Surgical Products, Inc. · Jun 1988
NIDEK AC-2000 LASER SYSTEM
K860011 · Nidek, Inc. · Feb 1986
ARGON/KRYPTON LASER SYSTEM 8500
K844209 · Cooper Lasersonics, Inc. · Feb 1985
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · Nidek, Inc. · Dec 1984
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE
K844198 · Nidek, Inc. · Dec 1984