Cleared Traditional

K925395 - TECHNOMED PULSOLITH 4000 LASER SYSTEM

K925395 is an FDA 510(k) clearance for TECHNOMED PULSOLITH 4000 LASER SYSTEM, manufactured by Teknomed, Inc.. The device is a Class 2 General Hospital device with product code LNK cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K925395 · Teknomed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
207d
Days
Class 2
Risk

K925395 is an FDA 510(k) clearance for the TECHNOMED PULSOLITH 4000 LASER SYSTEM. Classified as Laser For Gastro-urology Use (product code LNK), Class II - Special Controls.

Submitted by Teknomed, Inc. (Danvers, US). The FDA issued a Cleared decision on May 21, 1993 after a review of 207 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4810 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Teknomed, Inc. devices

FDA 510(k) Submission Details - K925395

510(k) Number K925395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1992
Decision Date May 21, 1993
Days to Decision 207 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 129d · This submission: 207d
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 General Hospital 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 K925395.
MDL-2000 LASERTRIPTER
K901723 · Candela Laser Corp. · Jul 1990
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
K880193 · Sharplan Lasers, Inc. · Apr 1988
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
K880256 · Sharplan Lasers, Inc. · Apr 1988
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
K880171 · Cooper Lasersonics, Inc. · Apr 1988
KTP/532 LASER
K873330 · Laserscope · Nov 1987
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
K871865 · Sharplan Lasers, Inc. · Sep 1987