Cleared Traditional

K780851 - CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC

K780851 is an FDA 510(k) clearance for CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC, manufactured by Varian Assoc., Inc.. The device is a Class 1 Ophthalmic device with product code HOB cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K780851 · Varian Assoc., Inc. · Ophthalmic device
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Jun 1978
Decision
39d
Days
Class 1
Risk

K780851 is an FDA 510(k) clearance for the CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC. Classified as Clamp, Muscle, Ophthalmic (product code HOB), Class I - General Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Varian Assoc., Inc. devices

FDA 510(k) Submission Details - K780851

510(k) Number K780851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1978
Decision Date June 30, 1978
Days to Decision 39 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
71d faster than avg
Panel avg: 110d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

HOB Device Classification - Class 1, General Controls

Product Code HOB Clamp, Muscle, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.