Cleared Traditional

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 (K911104) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

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

Submission Details

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.

Device Classification

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.