# K183563: Holinwon 30

- Pathway: 510(k) (Traditional)
- Applicant: Wontech Co., Ltd.
- Decided: Sep 5, 2019 after 259 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
Longest line of descent: 1 generation back to K041660 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041660: Trimedyne Holmium Laser Systems, Trimedyne, Inc. (2004) Summary page 6.

## Indications for use
The Holinwon 30 laser system is indicated for superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications. 1) Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, basal cell carcinomas, tattoo removal, lesions of skin and subcutaneous tissue, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), plantar warts, periungual and subungual warts, corns, debridement of decubitus ulcer, papillomas and skin tag vaporization. 2) Gastroenterological/GastrointestinaI Surgery, including: Cholecystectomy, varices, lysis of adhesions, esophagitis, appendectomy, esophageal ulcer, biopsy Mallory-Weiss tear, pylorostenotomy, gastric ulcer, benign and malignant lesions, duodenal ulcer, rectal polyps of sigmoid colon, non-bleeding ulcer, gall bladder calculi, gastric erosions, biliary/ bile duct calculi, colorectal cancer, benign and malignant neoplasm, gastritis, polyps, bleeding tumors, colitis, pancreatitis, ulcers, vascular malformations, angiodysplasia, telangiectasias, hemorrhoids and telangiectasias of the Osler-Weber- Rendu disease. 3) General Surgery of soft tissue, including: skin incision, herniorrhaphy, tissue dissection, tonsillectomy, excision of external tumors and lesions, lymphadenectomy, complete or partial resection of internal organs, partial nephrectomy, tumors and lesions, pilonidal cystectomy, tissue ablation, resection of lipoma, mastectomy, pelvic adhesiolysis, hepatectomy, debridement of decubitus ulcer, pancreatectomy, hemorrhoids, splenectomy, pilodidal cyst removal and repair, thyroidectomy, debridement of statis ulcer, parathyroidectomy and biopsy. 4) Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, urethral and penile hemangioma, invasive bladder carcinoma, bladder neck obstructions, urethral strictures, holmium laser incision/excision/resection/ ablation, hemoastasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH), lesions of the external genitalia, bladder, urethral and ureteral tumors and condylomas. 5) Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata 6) Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of kidney calculi, fragmentation of urethral calculi, treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed 7) Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, ligament and tendon release, knee synovectomy, contouring and sculpting of articular surfaces, chondromalacia and tears, debridement of inflamed synovial tissue, loose body debridement, capsulectomy in the knee, lateral retinacular release, chondroplasty in the knee, debridement of the degenerative knee, chondromalacia ablation and plica removal 8) Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, polypectomy, functional endoscopic sinus surgery, maxillary antrostomy, turbinate procedures (e.g.. turbinectomy), frontal sinusotomy, dacryocystorhinostomy (DCR), sphenoidotomy and ethmoidectomy 9) Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following: -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 symptom, 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 CTmyelography, 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/K183563
Methodology: https://510kreport.com/methodology