Cleared Traditional

K834305 - ARGON/KRYPTON ION LASER PHOTOCOAGULA

K834305 is an FDA 510(k) clearance for ARGON/KRYPTON ION LASER PHOTOCOAGULA, manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K834305 · Nidek, Inc. · Ophthalmic device
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Mar 1984
Decision
109d
Days
Class 2
Risk

K834305 is an FDA 510(k) clearance for the ARGON/KRYPTON ION LASER PHOTOCOAGULA. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Nidek, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 109 days - within the typical 510(k) review window.

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: 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 Nidek, Inc. devices

FDA 510(k) Submission Details - K834305

510(k) Number K834305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date March 16, 1984
Days to Decision 109 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
1d faster than avg
Panel avg: 110d · This submission: 109d
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 143
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K834305.
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
OPHTHALMIC ARGON LASER #700A
K832316 · Laser Industries , Ltd. · Jan 1984
LASER PHOTOCOAGULATOR 1520-A & K
K833533 · Britt Corp., Inc. · Jan 1984
BRITT KRYPTON LASERS 150K & 152K
K813492 · Britt Corp., Inc. · Jan 1982