Cleared Traditional

K843966 - ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

K843966 is an FDA 510(k) clearance for ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS, manufactured by American Medical Optics. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K843966 · American Medical Optics · Ophthalmic device
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Nov 1984
Decision
28d
Days
Class 2
Risk

K843966 is an FDA 510(k) clearance for the ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by American Medical Optics (Irvine, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 28 days - a notably fast clearance 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: 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 American Medical Optics devices

FDA 510(k) Submission Details - K843966

510(k) Number K843966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 08, 1984
Days to Decision 28 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
82d faster than avg
Panel avg: 110d · This submission: 28d
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 23
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K843966.
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
SLIT LAMP ATTACHMENT
K801877 · Cavitron Corp. · Sep 1980
PHOTOCOAGULATOR LASER
K780345 · Cavitron Corp. · May 1978
LAMP DELIVERY SYS.-PHOTOCOAGULATION
K772213 · Varian Assoc., Inc. · Dec 1977