# K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Mar 1, 2006 after 119 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963081 (1997). 2 ancestors in all.
33 later devices descend from it; 4 cite it directly.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010041: SLT Diffuser Fiber, Surgical Laser Technologies, Inc. (2001) Summary page 1.
- K963081: Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General Gynecological Applications, Indigo Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K071328: Visualase Thermal Therapy System (2007), 26 descendants of its own
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own
- K131278: Monteris Medical Neuroblate System (2013), 19 descendants of its own

## Recalls of this device
- Oct 14, 2022 · Class II · Z-0244-2023: Due to a defect in the outer pouch sterile seal
- Mar 23, 2018 · Class II · Z-2501-2018: Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test 
- Jul 27, 2017 · Class II · Z-0025-2018: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.
- Jun 7, 2017 · Class II · Z-2755-2017: Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow thr
- May 9, 2016 · Class II · Z-1672-2016: Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.

## Indications for use
The Visualase Cooled Laser Applicator System (VCLAS) is comprised of a Laser Diffusing Fiber (LDF), a Cooling Catheter System (CCS), and a Bare Tip Fiber (BTF). The Laser Diffusing Fiber (LDF) and Cooling Catheter System (CCS) are indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm. The Bare Tip Fiber (BTF) is intended for use in vaporization, cutting, ablation and coagulation of soft tissues with or without scopes or handpieces, for contact or non-contact surgery in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology for the wavelength range of 800nm through 1064nm.

Source page: https://510kreport.com/device/K053087
Methodology: https://510kreport.com/methodology