Cleared Traditional

K843965 - ARGON LASER PHOTOCOAGULATOR SYS

K843965 is an FDA 510(k) clearance for ARGON LASER PHOTOCOAGULATOR SYS, manufactured by American Medical Optics. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K843965 · American Medical Optics · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
26d
Days
Class 2
Risk

K843965 is an FDA 510(k) clearance for the ARGON LASER PHOTOCOAGULATOR SYS. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by American Medical Optics (Irvine, US). The FDA issued a Cleared decision on November 6, 1984 after a review of 26 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 American Medical Optics devices

FDA 510(k) Submission Details - K843965

510(k) Number K843965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date November 06, 1984
Days to Decision 26 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
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

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 114
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K843965.
HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
K850572 · Hgm, Inc. · Apr 1985
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
K844358 · Coherent Medical Group · Jan 1985
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K844668 · Cooper Lasersonics, Inc. · Jan 1985
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE
K842250 · American Medical Optics · Aug 1984
AMERI. MEDICAL OPTICS ARGON LASER PHOTO
K842251 · American Medical Optics · Aug 1984
MODEL 4000 MD-YAG LASER FOR MALIGNANT
K842412 · Cooper Lasersonics, Inc. · Jun 1984