510(k) · Cleared
ClearedHolinwon 30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wontech Co., Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 5, 2019 as substantially equivalent to K041660 (Trimedyne, Inc., 2004) after a 259-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 5, 2019
- Review
- 259 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041660 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041660 Trimedyne Holmium Laser SystemsTrimedyne, Inc. · 2004
- This deviceK183563 Holinwon 30Wontech Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041660 | Trimedyne Holmium Laser Systems | Trimedyne, Inc. | 2004 | — |
| 0 (this device) | K183563 | Holinwon 30 | Wontech Co., Ltd. | 2019 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041660 | Trimedyne Holmium Laser SystemsSummary page 6…)] The identified predicate devices within this submission are shown as follow: Primary Predicate device 510(k) Number: K041660 Applicant: Trimedyne.Inc. Classification Name: Powe… | 2004 |
| † | K050738 | FT Fiber Optic Delivery Systems | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (580 words)
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183563: Holinwon 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183563
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026