Cleared Traditional

K841856 - AMER. MED. OPTICS ARGON/KRYPTON LASER

K841856 is an FDA 510(k) clearance for AMER. MED. OPTICS ARGON/KRYPTON LASER, 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 35-day FDA review.

K841856 · American Medical Optics · Ophthalmic device
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Jun 1984
Decision
35d
Days
Class 2
Risk

K841856 is an FDA 510(k) clearance for the AMER. MED. OPTICS ARGON/KRYPTON LASER. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by American Medical Optics (Walker, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 35 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 - K841856

510(k) Number K841856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1984
Decision Date June 07, 1984
Days to Decision 35 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
75d faster than avg
Panel avg: 110d · This submission: 35d
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 K841856.
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
AMER. MED. OPTICS ARGON LASER PHOTO
K841855 · American Medical Optics · Jun 1984
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K840590 · Hgm, Inc. · May 1984
MONITOR CO2 LASER SURGICAL SYSTEM
K840145 · Cooper Lasersonics, Inc. · Apr 1984
MEDICAL LASER ENDOCOAGULATOR 5K
K840854 · Hgm, Inc. · Apr 1984