Holinwon 30

Wontech Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K183563
Device name
Holinwon 30
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-12-20
Decision date
2019-09-05
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacingVascular treatmentPigment treatment
Primary application
Surgical cutting
Classification source
AI classified

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/Gastrointestinal 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, hemostasis, 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 retinac

Intended 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/Gastrointestinal 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, hemostasis, 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 acuminate 6) Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of k

Device Description

The Holinwon 30 Laser System is a pulsed solid-state Holmium:YAG laser system designed to deliver infrared laser energy with a wavelength of 2100 nm and a nominal pulse width of 600 microseconds. Menu driven control options allow the operator to select the pulse energy and the pulse repetition rate (frequency).

Summary parsed at:2026-06-01 05:54:59 UTC

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