Cleared Traditional

ARGON LASER SURGICAL SYSTEM 770 (K833387) - FDA 510(k) Clearance

K833387 · Cooper Medical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
202d
Days
-
Risk

K833387 is an FDA 510(k) clearance for the ARGON LASER SURGICAL SYSTEM 770.

Submitted by Cooper Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1984 after a review of 202 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cooper Medical Corp. devices

Submission Details

510(k) Number K833387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1983
Decision Date April 18, 1984
Days to Decision 202 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 115d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -