The Holinwon 30 laser system is indicated for superficial incision, 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, in 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, coms, debridement of decubitus ulcer, papillomas and skin tag vaporization.
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 turnors, colitis, pancreatitis, ulcers, vascular malformations, angiodysplasia, telangiectasias, hemorthoids and telangiectasias of the Osler-Weber-Rendu disease.
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, pilodidal cyst removal and repair, thyroidectomy, debridement of statis ulcer, parathyroidectomy and biopsy.
Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, urethral and penile hemangioma, invasive bladder carcinoma, bladder neck obstructions, holmium laser incision/excision/resection/ ablation, hemoastasis, vaporization, and enucleation in the treatment of benign prostatic (BPH), lesions of the external genitalia, bladder, urethral and ureteral tumors and condylomas.
Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
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
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, ligament and tendon release, knee synovectomy, contouring 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
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
Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectorny: 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/Discectorny 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)

Device Description

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

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Holinwon 30 laser system. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with pre-defined acceptance criteria and statistically significant results.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of typical clinical performance studies for novel devices (e.g., diagnostic accuracy studies for AI). Instead, it focuses on non-clinical bench testing and comparison to a predicate device.

Here's an explanation of why the requested information is not present and what is reported in the document:

A table of acceptance criteria and the reported device performance: This document does not present clinical performance acceptance criteria or report performance data against such criteria. The "performance" reported are the results of non-clinical bench tests (electrical safety, EMC, software validation, biocompatibility) demonstrating compliance with recognized standards.

However, for the sake of illustrating the comparison to the predicate device, which is the core of a 510(k) submission for substantial equivalence, a table can be constructed from page 7:

Feature	Proposed Device (Holinwon 30)	Predicate Device (OmniPulse Jr.™)
K Number	K183563	K041660
Manufacturer	WON TECH Co., Ltd.	Trimedyne.Inc.
Model	Holinwon 30	OmniPulse Jr.™
Product Code	GEX	GEX
Intended Use/Ind. for Use	Superficial incision, excision, etc. in multispecialty applications (detailed list provided)	Superficial incision, excision, etc. in multispecialty applications (same as proposed)
Laser Type	Holmium: YAG laser	Holmium: YAG laser
Wavelength	2100 nm	2100 nm
Pulse Energy	0.1 - 3 J	0.2 - 3.5 J
Pulse Duration	600 microseconds ± 10%	350 microseconds
Repetition Rate	2 - 15 Hz	5 - 20 Hz
Output Power	0.2 - 30 W	1.4 - 30 W
Aiming Beam	Green, 532 nm ± 10%, < 5 mW, Class 3R	Red, 3 mW maximum, Class 3R
Electrical Consumption	230 VAC, 5.0 kVA (21 A), 50 Hz, single phase	230 VAC, 3.5 kVA, 15 A, 50/60 Hz, single phase
Dimensions (W x L x H)	37 cm x 71.4 cm x 89.4 cm	53 cm x 50 cm x 91 cm
Weight	70 kg	104 kg
Cooling	Self-contained air/water	Self-contained air/water

The "acceptance criteria" here is that the differences in these characteristics "do not raise any new safety and effectiveness issues."

Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission. The "tests" mentioned are non-clinical bench tests (electrical safety, EMC, software validation, biocompatibility), not clinical studies with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in the clinical sense (e.g., diagnosis from expert consensus or pathology) is not established or used as part of this 510(k) submission, as no human-in-the-loop or standalone AI performance study was conducted.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no clinical test set to adjudicate.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a laser surgical instrument, not an AI-powered diagnostic device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical laser surgical instrument, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established or used for performance evaluation in this 510(k) submission.
The sample size for the training set: Not applicable. The device is a physical laser system, not an AI model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary from the document:

Clinical Studies: "No clinical studies were considered necessary and performed." (Page 9)
Proof of meeting acceptance criteria: The device demonstrates compliance with relevant international and national standards for electrical safety (ES60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60601-2-22, IEC 60825-1), and biocompatibility (ISO 10993 series). Software validation was also performed for the "MODERATE level of concern software." These non-clinical tests serve as the basis for demonstrating safety and performance.
Basis for Clearance: Substantial equivalence to a predicate device (OmniPulse Jr.™) by demonstrating that technological differences (pulse duration, aiming beam) do not raise new safety or effectiveness issues.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 5, 2019

Won Tech Co., Ltd. Jake Yu Staff of Regulatory Affairs 64 Techno 8-Ro, Yuseong-gu Daejeon, 34028 Kr

Re: K183563

Trade/Device Name: Holinwon 30 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 17, 2019 Received: August 6, 2019

Dear Jake Yu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva Pandya Assistant Director (Acting) DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183563

Device Name Holinwon 30

Indications for Use (Describe)

The Holinwon 30 laser system is indicated for superficial incision, 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, in 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, coms, debridement of decubitus ulcer, papillomas and skin tag vaporization.
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 turnors, colitis, pancreatitis, ulcers, vascular malformations, angiodysplasia, telangiectasias, hemorthoids and telangiectasias of the Osler-Weber-Rendu disease.
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, pilodidal cyst removal and repair, thyroidectomy, debridement of statis ulcer, parathyroidectomy and biopsy.
Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, urethral and penile hemangioma, invasive bladder carcinoma, bladder neck obstructions, holmium laser incision/excision/resection/ ablation, hemoastasis, vaporization, and enucleation in the treatment of benign prostatic (BPH), lesions of the external genitalia, bladder, urethral and ureteral tumors and condylomas.
Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
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
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy, ligament and tendon release, knee synovectomy, contouring 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
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

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Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectorny: 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/Discectorny 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)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange graphic on the left, followed by the text "WONTECH" in red and gray. The graphic is a stylized "W" shape.

1-6. 510(k) Summary

K183563

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

September 1, 2019

Submitter's Information [21 CFR 807.92(a)(1)] 2.

• Name of Sponsor:- Address:	WON TECH Co., Ltd.64 Techno 8-Ro, Yuseong-gu, DaejeonRepublic of Korea, 34028
• Contact Name:- Telephone No.:- Fax No.:- Email Address:	Jake Yu/ Staff of Regulatory Affair+82-70-7836-6921+82-70-934-9491regulatory@wtlaser.com
• Registration No.:	3006985208

Name of Manufacturer: ● Same as Sponsor Address: Same as Sponsor -

1. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name	Holinwon 30
Common Name	Holmium Laser System
Device Classification Name	Powered Laser Surgical Instrument
Regulation Number	21CFR878.4810
Classification Product Code	GEX
Device Class	Class II
510k Review Panel	General & Plastic Surgery

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Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular shape with a white "W" inside it. To the right of the circular shape, the text "WONTECH" is written in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.

2. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)|

The identified predicate devices within this submission are shown as follow:

Primary Predicate device

• 510(k) Number:	K041660
• Applicant:	Trimedyne.Inc.
• Classification Name:	Powered Laser Surgical Instrument
• Trade Name:	OmniPulse Jr.TM

3. Description of the Device [21 CFR 807.92(a)(4)]

4. Indications for Use [21 CFR 807.92(a)(5)]

The Holinwon 30 laser system is indicated for superficial incision, excision, 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, 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.

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. Holinwon 30 General Information

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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular design on the left, followed by the text "WONTECH" in red and gray. The orange design appears to be a stylized letter "W" inside of a circle.

Genihourinary 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 acuminate

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

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

Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including:

endosinus surgery, polypectomy, functional endoscopic sinus surgery, maxillary frontal antrostomy, turbinate procedures turbinectomy), sinusotomy, dacryocystorhinostomy (DCR), sphenoidotomy and ethmoidectomy

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 symptoms, 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,

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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of a stylized "W" symbol in orange and yellow gradient, followed by the text "WONTECH" in red and gray. The "WON" part of the text is in red, while the "TECH" part is in gray.

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)

5. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the Holinwon 30 and the predicate devices:

	Proposed Device	Predicate Device
K Number	K183563	K041660
Manufacturer	WON TECH Co., Ltd.	Trimedyne.Inc.
Model	Holinwon 30	OmniPulse Jr.TM
Product Code	GEX	GEX
Intended Use/Indications for Use	The Holinwon 30 Laser System isindicated for superficial incision,excision, resection, ablation,coagulation, hemostasis, andvaporization, with or without anendoscope, in multispecialtyapplications.*Refer to '4. Indications for use'above for more detail.	The OmniPulse Jr.TM LaserSystem is indicated for superficialincision, excision, resection,ablation, coagulation, hemostasis,and vaporization, with or withoutan endoscope, in multispecialtyapplications.*Same as '4. Indications for use'above.
Laser Type	Holmium: YAG laser	Holmium: YAG laser
Wavelength	2100 nm	2100 nm
Pulse Energy	0.1 - 3 J	0.2 - 3.5 J
Pulse Duration	600 microseconds ± 10%	350 microseconds
Repetition Rate	2 - 15 Hz	5 - 20 Hz
Output Power	0.2 - 30 W	1.4 - 30 W
Aiming Beam	Green, 532 nm ± 10%, less than 5mW, Class 3R	Red, 3 mW maximum, Class 3R
Electricalconsumption	230 VAC, 5.0 kVA(21 A), 50 Hz,single phase	230 VAC, 3.5 kVA, 15 A, 50/60 Hz,single phase
Dimensions(W x L x H)	37 cm× 71.4 cm× 89.4 cm	53 cm x 50 cm x 91 cm
Weight	70 kg	104 kg
Cooling	Self-contained air/water	Self-contained air/water

The key differences between Holinwon 30 and the predicate device are pulse duration and aiming beam, and which do not raise any new safety and effectiveness issues. The Holinwon 30 and predicate device have the same output power and pulse energy.

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Image /page/8/Picture/0 description: The image shows the logo for WONTECH. The logo consists of a stylized letter "W" in orange and yellow, followed by the text "WON" in red and "TECH" in gray. The "W" is made up of three curved lines that intersect in the middle, creating a sense of movement and energy.

Verification and validation activities were conducted to establish the performance and safety characteristics of the Holinwon 30. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the Holinwon 30 is considered substantially equivalent to the predicate device.

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1) Electrical Safety, Electromagnetic Compatibility and Performance

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

StandardsNo.	StandardsOrganization	Standard Title	Version	PublicationYear
ES60601-1	ANSI AAMI	Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and EssentialPerformance	Edition 3.1	2012
60601-1-2	IEC	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety - Collateral Standard:Electromagnetic Compatibility - Requirements andTests	Edition 4	2014
60601-2-22	IEC	Medical Electrical Equipment - Part 2-22: ParticularRequirements for Basic Safety and EssentialPerformance of Surgical, Cosmetic, Therapeutic andDiagnostic Laser Equipment	Edition 3.1	2012
60825-1	IEC	Safety of Laser Products - Part 1: EquipmentClassification, and Requirements	Edition 2	2007

2) Software Validation

The Holinwon 30 contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

1. Biocompatibility
  The optical fiber cable directly contacted with patient has got 510(k) clearance, K050738. According to the recommendations of ISO 10993-1 and FDA Blue Book Memo #G95-1, the following tests were performed for the certificate and clearance process:

-Cytotoxicity according to ISO 10993-5

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-Intracutaneous reactivity according to ISO 10993-10 -Sensitization according to ISO 10993-10

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

Conclusion [21 CFR 807.92(b)(3)] 6.

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd., concludes that the Holinwon 30 is substantially equivalent in safety and effectiveness to the predicate device as described herein.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.