Cleared Traditional

K911104 - PHOTCOAGULATOR KR-568 LASER SPECTRUM EL...

K911104 is an FDA 510(k) clearance for PHOTCOAGULATOR KR-568 LASER SPECTRUM EL..., manufactured by Hgm Medical Laser Systems, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FEX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911104 · Hgm Medical Laser Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
90d
Days
Class 1
Risk

K911104 is an FDA 510(k) clearance for the PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1. Classified as Instrument, Catheter, Punch (product code FEX), Class I - General Controls.

Submitted by Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 11, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K911104

510(k) Number K911104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1991
Decision Date June 11, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

FEX Device Classification - Class 1, General Controls

Product Code FEX Instrument, Catheter, Punch
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5090
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.