510(k) Report

510(k) · Cleared

Cleared

Holinwon 30

K183563510(k) TraditionalCleared Sep 5, 2019259-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

K041660 · Trimedyne Holmium Laser Systems · Trimedyne, Inc. · 20040
  1. Root · 1 generation backK041660 Trimedyne Holmium Laser SystemsTrimedyne, Inc. · 2004
  2. This deviceK183563 Holinwon 30Wontech Co., Ltd. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K041660Trimedyne Holmium Laser SystemsTrimedyne, Inc.2004—
0 (this device)K183563Holinwon 30Wontech Co., Ltd.2019—
FIG. 1 — Lineage of K183563, 2004–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K041660Trimedyne Holmium Laser Systems
Summary 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…
Trimedyne, Inc.2004—
†K050738FT Fiber Optic Delivery SystemsFibertech GmbH20055

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 devices

GEX 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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