# K992574: Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models 1210-VHP, 1500A

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Oct 29, 1999 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Coherent VersaPulse Select Dual Wavelength Surgical Laser: named in the summary without a submission number
- (no number) Trimedyne Optilase® Model 1000-100 Nd:YAG Laser System: named in the summary without a submission number
- (no number) Nortech Autolith Lithotriptor Electro-Hydraulic System: named in the summary without a submission number

## Most influential descendants
- K994273: Model 1000 Holmium Laser System (2000), 0 descendants of its own

## Indications for use
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/ Gastrointestinal Surgery, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bilg,duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease. Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications: Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas. General Surgery of soft tissues, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation. Genitourinary Surgery, including: superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia. Gynecological Surgery during open and endoscopic procedures. Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi. Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, and debridement of the degenerative knee. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g.. turbinectomy), and dacryocystorhinostomy (DCR). Percutaneous Lumbar Discectomy, soft and cartilagineous lissue.

Source page: https://510kreport.com/device/K992574
Methodology: https://510kreport.com/methodology