Medical Device Manufacturer · US , Walker , MI

Trimedyne, Inc. - FDA 510(k) Cleared Devices

58 submissions · 58 cleared · Since 1981

Total

Cleared

Denied

Trimedyne, Inc. is a manufacturer of Holmium:YAG lasers and surgical peripherals. The company specializes in laser-based surgical solutions for minimally invasive procedures across multiple specialties including urology, orthopedics, spine surgery, and general surgery.

Trimedyne has received 58 FDA 510(k) clearances from 58 total submissions since its first clearance in 1981. The company's regulatory focus centers on General & Plastic Surgery devices, which represent 83% of its submission history. The latest clearance on record dates to 2005, reflecting the company's historical role in surgical laser technology development.

Notable product lines include the OmniPulse and OmniPulse MAX Holmium laser systems, along with complementary surgical accessories such as optical fibers, side-firing needles, and handpieces. These devices support indications spanning lithotripsy, urological procedures, orthopedic joint surgery, spinal disc decompression, and gynecological applications.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.

FDA 510(k) Regulatory Record - Trimedyne, Inc.

58 devices

1-12 of 58