SLT CLMD Contact Laser

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K884815 ↗

FDA Product Code

LLO

Device Class

Class II

Regulation

21 CFR Part 874.4500

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Slt Thermalite Diode Laser Series, Diode 980, 810, 940

  Class II

  FDA 510(k) K952661 Active Cleared 6 Oct 1995

• Slt Multidimensional Contact Laser System

  Class II

  FDA 510(k) K931286 Active Cleared 6 Feb 1995

• SLT Contact Laser System Endophotocoagulation

  Class II

  FDA 510(k) K882441 Active Cleared 26 Sep 1988

• Sacs, Independent Fiber Coolant System

  Class II

  FDA 510(k) K952754 Active Cleared 31 Jul 1995

• S.L.T. Contact Laser System

  Class II

  FDA 510(k) K855100 Active Cleared 26 Feb 1986

• Slt Fumich Probe Guide

  Class II

  FDA 510(k) K960821 Active Cleared 16 May 1996

See all devices from Surgical Laser Technologies, Inc. →

• What is the SLT CLMD Contact Laser used for?

  The SLT CLMD Contact Laser is specifically designed for otolaryngological (ENT) procedures, delivering precise laser applications in the ear, nose, and throat. Its neodymium-doped yttrium aluminum garnet (Nd:YAG) laser source allows controlled tissue interaction, making it suitable for targeted surgical interventions in these delicate areas. This ensures minimal collateral damage and improved surgical outcomes.

• Is the SLT CLMD Contact Laser single-use or reusable?

  The SLT CLMD Contact Laser can be supplied as either single-use or reusable, depending on the manufacturer’s specifications. For reusable units, strict adherence to cleaning, sterilization, and maintenance protocols is required to ensure safety and performance. Always follow the manufacturer’s guidelines to determine the intended use and handling instructions for your specific device.

• What regulatory approvals does the SLT CLMD Contact Laser hold?

  The SLT CLMD Contact Laser holds FDA 510(k) clearance under the reference number K884815, classified as a Class II device under product code LLO. This clearance indicates it is deemed substantially equivalent to a legally marketed device and meets regulatory requirements for safety and effectiveness in otolaryngological applications. Additional regulatory references include FEI numbers 3002808001, 3003761012, and 3005747797.

• How should the SLT CLMD Contact Laser be stored?

  The SLT CLMD Contact Laser must be stored in accordance with standard laser safety protocols to maintain its integrity and functionality. This includes protecting it from physical damage, moisture, and contamination, as well as ensuring it is kept in a secure, controlled environment when not in use. Always refer to the manufacturer’s instructions for specific storage recommendations, particularly if the device is reusable.

• Does the SLT CLMD Contact Laser have any MRI safety information?

  The provided specifications for the SLT CLMD Contact Laser do not include any details regarding MRI safety. If MRI compatibility is a concern for your clinical setting, additional information or testing may be required to ensure safe use in proximity to MRI equipment. Always consult the manufacturer for clarification on this matter.