Cleared Traditional

K864948 - ADVANCED HAND HELD CO2 LASER/HH-550 FOR...

K864948 is an FDA 510(k) clearance for ADVANCED HAND HELD CO2 LASER/HH-550 FOR..., manufactured by Bio Quantum Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNK cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K864948 · Bio Quantum Technologies, Inc. · Gastroenterology & Urology device
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Mar 1987
Decision
103d
Days
Class 2
Risk

K864948 is an FDA 510(k) clearance for the ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Bio Quantum Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on March 30, 1987 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4810 - 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 Bio Quantum Technologies, Inc. devices

FDA 510(k) Submission Details - K864948

510(k) Number K864948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1986
Decision Date March 30, 1987
Days to Decision 103 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
27d faster than avg
Panel avg: 130d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNK Device Classification - Class 2, Special Controls

Product Code LNK Laser For Gastro-urology Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LNK Laser For Gastro-urology Use

All 26
Devices cleared under the same product code (LNK) and FDA review panel - the closest regulatory comparables to K864948.
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · Directed Energy, Inc. · May 1987
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
K871030 · Directed Energy, Inc. · May 1987
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
K871031 · Directed Energy, Inc. · May 1987
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
K862598 · Laserscope · Nov 1986
CONTACT TIPS
K861955 · Cooper Lasersonics, Inc. · Aug 1986
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
K861331 · Trimedyne, Inc. · Aug 1986