LM-150HT Light Source

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K911212 ↗

FDA Product Code

ESI

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• LM 1000 Cryosurgical Accessories

  Class II

  FDA 510(k) K854767 Active Cleared 24 Jan 1986

• Lm- Lap 10 High Flow Insufflator

  Class II

  FDA 510(k) K914201 Active Cleared 9 Jan 1992

• Colposcopes and Accessories

  Class II

  FDA 510(k) K940094 Active Cleared 25 Apr 1995

• Max-E-Vac

  Class II

  FDA 510(k) K920217 Active Cleared 23 Jul 1992

• Lm-100/200LOW Flow Insufflator

  Class II

  FDA 510(k) K912789 Active Cleared 20 Sep 1991

• Lm-1Z Zoom Scope

  Class II

  FDA 510(k) K902313 Active Cleared 4 Sep 1990

See all devices from Leisegang Medical, Inc. →

• Is the LM-150HT Light Source intended for single-use or can it be reused in multiple procedures?

  The LM-150HT Light Source is explicitly designed as a reusable instrument, meaning it is meant to be processed and reused in controlled clinical settings like operating rooms or procedural suites. Since it is not described as sterile out-of-package, standard surgical instrument processing protocols should be followed between uses.

• What types of procedures is the LM-150HT Light Source typically used for?

  The LM-150HT is a high-intensity illumination tool designed to provide focused light for surgical and diagnostic procedures where enhanced visibility in confined or complex anatomical areas is critical. While the exact clinical applications aren’t detailed, its classification under Endoscopic Surgical Instruments (ESI) suggests it may be used in minimally invasive surgeries or procedures requiring precise lighting, such as arthroscopy or laparoscopic surgeries.

• How is the LM-150HT Light Source regulated, and what does its FDA clearance mean for purchasing decisions?

  The LM-150HT holds an FDA 510(k) clearance (K911212) under the Traditional Review pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates it meets FDA safety and effectiveness standards for its intended use as a reusable illumination tool in surgical settings. Purchasers should confirm compatibility with their facility’s existing surgical instrument inventory and processing protocols.

• Can the LM-150HT Light Source be used in an MRI environment, or are there any safety concerns?

  The LM-150HT is not classified as MRI-safe or MRI-conditional, meaning it should not be used in an MRI environment. If MRI compatibility is required for your facility, alternative lighting solutions should be considered to avoid potential interference or safety risks during imaging procedures.

• What materials is the LM-150HT Light Source made from, and does this affect its durability or maintenance?

  The LM-150HT is constructed from a polymer, natural-absorbable gelatin material, which may influence its durability and maintenance requirements compared to traditional metal or plastic surgical instruments. Since it is reusable, proper cleaning, sterilization, and inspection protocols must be followed to ensure longevity and functionality. The manufacturer’s guidelines (provided by Leisegang Medical, Inc.) should be consulted for specific care instructions.