Cleared Traditional

K844209 - ARGON/KRYPTON LASER SYSTEM 8500

K844209 is an FDA 510(k) clearance for ARGON/KRYPTON LASER SYSTEM 8500, manufactured by Cooper Lasersonics, Inc.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K844209 · Cooper Lasersonics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
98d
Days
Class 2
Risk

K844209 is an FDA 510(k) clearance for the ARGON/KRYPTON LASER SYSTEM 8500. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Cooper Lasersonics, Inc. (Santa Clara, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 98 days - within the typical 510(k) review window.

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 Cooper Lasersonics, Inc. devices

FDA 510(k) Submission Details - K844209

510(k) Number K844209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1984
Decision Date February 06, 1985
Days to Decision 98 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
12d faster than avg
Panel avg: 110d · This submission: 98d
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 15
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K844209.
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · Advanced Surgical Products, Inc. · Jun 1988
NIDEK AC-2000 LASER SYSTEM
K860011 · Nidek, Inc. · Feb 1986
SYSTEM 930 ARGON PHOTOCOAGULATOR
K844356 · Coherent Medical Group · May 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