# K013974: Rmnipulse Holmium Laser System/1210; Max/1210-VHP; JR. 1230-30; N/a 1500-a

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Sep 23, 2002 after 294 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Standard surgical instruments, such as knives and forceps: named in the summary without a submission number

## Indications for use
Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications: Percutaneous Lumbar Disc Decompression/Discectomy in soft, cartilaginous, and bony tissue, including: foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy in soft tissue, in patients with: Uncomplicated ruptured or herniated discs Neck pain with radiation down the arm Symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms Positive electromyography and/or nerve conduction studies No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication) Percutaneous Thoracic Disc Decompression/Discectomy in soft tissue, in patients with: Uncomplicated ruptured or herniated discs Thoracic and intercostal intractable pain Paresthesias at levels appropriate to the herniated discs visualized on MRI and CT-myelography MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms No improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction. bed rest, exercises, and medication)

Source page: https://510kreport.com/device/K013974
Methodology: https://510kreport.com/methodology