Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

Device Description

Azure consists of main body, articulated arm, handpiece, foot switch, power cord, protective glasses. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD manipulated by simple hand touch, which facilitates operation of the equipment at user's convenience. The laser output is released by the foot switch. This laser operation device uses CO2 medium based wave of 10.6 micrometers.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Azure," a laser surgical instrument. The document focuses on demonstrating the substantial equivalence of the Azure device to a legally marketed predicate device (Finexel, K213557), and as such, it does not contain the specific information requested about acceptance criteria and a study proving those criteria are met for the novel aspects of the device's performance.

Instead, the document details physical and technical characteristics and compliance with recognized standards. Since no new clinical claims are being made that would necessitate a clinical study to establish acceptance criteria, the document states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert adjudication, or MRMC studies for a novel feature. The device is being cleared based on its substantial equivalence to an existing device, implying that its performance is expected to be comparable to the predicate for its stated indications for use.

Here's a summary of the information available based on the provided text, focusing on how the device does meet criteria for regulatory clearance, even if not in the way a study for novel performance claims would typically describe:

The Azure device is a Laser Surgical Instrument (Product Code: GEX, Regulation Number: 21 CFR 878.4810, Class II). Its stated Indications for Use are: "Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry."

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the context of a performance study demonstrating novel capabilities. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device. The performance data provided are related to technical specifications and safety standards.

Acceptance Criteria Category (implied for substantial equivalence/safety)	Reported Device Performance (Azure)
Biocompatibility	Passed (evaluated in accordance with ISO 10993-1)
Shelf Life	Expected service life rationale report attached to submission.
Software Verification & Validation	Verification and validation testing conducted on software interface and firmware, documentation provided as recommended by FDA guidance.
Electromagnetic Compatibility (EMC)	Passed (complied with IEC 60601-1-2)
Electrical Safety	Passed (complied with IEC 60601-1)
Laser Safety	Passed (complied with IEC 60825-1)
Usability	Passed (complied with IEC 60601-1-6)
General Performance (Laser Surgical Instrument)	Passed (conducted on Azure according to IEC 60601-2-22). Specific quantitative performance metrics are not detailed, but overall compliance with the standard is stated.
Wavelength	10,600nm (Same as predicate)
Laser Type (Source)	CO2 Laser (Same as predicate)
Pulse Frequency	1Hz ~ 500Hz (Different from predicate, but falls within its implied range, so "will not raise any issues in safety and effectiveness.")
Pulse Duration	60 µs ~ 900 µs (Different from predicate, but falls within its implied range, so "will not raise any issues in safety and effectiveness.")
Energy (max)	30W (CW mode), 15J (Ultra mode) (Different from predicate, but falls within its implied range, so "will not raise any issues in safety and effectiveness.")
Spot Size	0.4mm (100mm Handpiece), 0.2mm (50mm Handpiece), 0.2~1.0mm (Zoom Handpiece) (Slightly Different - "difference... is very small, approximately 0.2mm, so it will not affect safety or effectiveness.")
Fluency (Energy Density)	72243J/cm² (cw, 50mm) (Different from predicate, but falls within its implied range, so "will not raise any issues in safety and effectiveness.")
Aiming laser	5mW, 650nm, InGaAIP (Same as predicate)
Laser Delivery	Articulated Arm (Same as predicate)
User Interface	LCD Touch Screen (Same as predicate)

2. Sample size used for the test set and the data provenance:

Test set for non-clinical testing: Not specified as a "sample size" in the context of clinical trials. The testing refers to engineering and safety compliance tests on the device itself.
Data provenance: The non-clinical testing was performed for this 510(k) Notification by DAESHIN ENTERPRISE CO., Ltd. in South Korea (company address in Seoul, Republic of Korea). It is internal testing to demonstrate compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The document describes non-clinical engineering and safety tests, not studies requiring expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The document describes non-clinical engineering and safety tests.

5. 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:

No. This is a laser surgical instrument, not an AI-assisted diagnostic or imaging interpretation device. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not a standalone algorithm. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. "Ground truth" in the sense of clinical accuracy is not established for this type of device in this 510(k). The "truth" for safety and performance is based on compliance with harmonized standards.

8. The sample size for the training set:

Not applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 2024

Daeshin Enterprise Co., Ltd. % Seung Ahn CEO Chemron FDA Korea S-303, S-304, 338, Hakdong-ro Gangnam-gu. Seoul 06099 Korea, South

Re: K231514

Trade/Device Name: Azure 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: January 12, 2024 Received: January 12, 2024

Dear Seung Ahn:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Digitally signed by Shlomit Shlomit Halachmi -S Date: 2024.02.14 Halachmi -S 15:38:39 -05'00'

Shlomit Halachmi

for

Tanisha Hithe Assistant Director

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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) K231514

Device Name Azure

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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#401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-2108-2198 / Fax: +82-2-2108-2181

510(k) Summary

510(k) number: K231514

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date Prepared: Feb 13, 2024

I. Submitter

Submitter DAESHIN ENTERPRISE CO., Ltd. Kyu Kim #401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu Seoul, Republic of Korea Email: dse khw@dselaser.com Tel: +82-2-2108-2198 Fax: +82-2-2108-2181

Official Correspondent Chemron FDA Korea Seung Hyun Ahn S-303, S-304, 338, Hakdong-ro, Gangnam-gu, Seoul, Republic of Korea Email: chemronsayou@naver.com / ahn 3060@naver.com Tel: +82-2-568-7744 / Fax: +82-2-543-4746

II. Subject Device

Trade (Proprietary) Name: Azure
Manufacturer: DAESHIN ENTERPRISE CO., Ltd.
Common Name: Powered Laser Surgical Instrument
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Code: GEX
Review Panel: General & Plastic Surgery
Regulation Number: 21 CFR 878.4810
Device Classification: Class II
Submission Type: 510(k) Traditional

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DAESHIN ENTERPRISE CO., Ltd. #401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-2108-2198 / Fax: +82-2-2108-2181

III. Predicate Device

The subject device is substantially equivalent to the following predicate device, which is legally marketed.

Predicate Device	510(k) Number	Company Name
Finexel	K213557	SNJ Co., Ltd

IV. General Description

V. Indications for Use

Azure(DS-22CO) is intended for use in non-fractionated mode for Incision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

VI. Comparison of Technological Characteristics with the Predicate Device

Azure has a substantially equivalent to the predicated device with respect to the intended use and basic technological characteristics. Please refer to the next page for the comparison table.

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#401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-2108-2198 / Fax: +82-2-2108-2181

Category	Predicate Device(SNJ Co., Ltd)	Subject Device(DAESHIN ENTERPRISECO., Ltd.)	Decision	Explanation
Product Name	Finexel	Azure	-	-
Manufacturer	SNJ Co., Ltd	DAESHIN ENTERPRISE CO.,Ltd.	-	-
510K Number	K213557	K231514	-	-
ClassificationProduct Code	GEX	GEX	Same	-
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	Same	-
Class	Class II	Class II	Same	-
Intended Use	Finexel CO2 laser system isintended for use isn non-fractionated mode forIncision, Excision, Ablation,Vaporization, andCoagulation of Human bodysoft Tissues in Dermatology,Plastic surgery, GeneralSurgery, Gynecology,Neurosurgery, and inPodiatry.	Azure(DS-22CO) is intendedfor use in non-fractionatedmode for Incision, Excision,Ablation, Vaporization, andCoagulation of Human bodysoft Tissues in Dermatology,Plastic surgery, GeneralSurgery, Gynecology,Neurosurgery, and inPodiatry.	Same	-
Dimension andWeightof Device	350(W) x 400(L) x 1000(H)mmApprox. 50kg	330(W) x 330(L) x 1060(H)mmApprox. 45kg	Different	The dimensions and weight ofthe subject device are differentfrom those of the predicatedevice. However, the dimensionand weight difference is only inphysical specification, which willnot raise any issues in safetyand effectiveness.
Wavelength	10,600nm	10,600nm	Same	-
Laser Type(Source)	CO2 Laser	CO2 Laser	Same
PulseFrequency	N/A	1Hz ~ 500Hz	Different	The pulse frequency of the subject device is different from that of the predicate device, but it falls within the range of values for the predicate device. Therefore, it will not raise any issues in safety and effectiveness.
Pulse Duration	N/A	60 $\mu$ s ~ 900 $\mu$ s	Different	The pulse duration of the subject device is different from that of the predicate device, but it falls within the range of values for the predicate device. It will not raise any issues in safety and effectiveness.
Energy (max)	N/A	30W (CW mode)15J (Ultra mode)	Different	It is different from the Predicate Device, but it is included within the range of the value the Predicate Device and it will not raise any issues in safety and effectiveness.
Spot Size	N/A	0.4mm(100mm Handpiece)0.2mm(50mm Handpiece)0.2~1.0mm(ZoomHandpiece)	SlightlyDifferent	The difference in spot size is very small, approximately 0.2mm, so it will not affect safety or effectiveness.
Fluency(EnergyDensity)	N/A	72243J/cm²(cw, 50mm)	Different	Fluency of the subject device is different from that of the predicate device, but it falls within the range of values for the predicate device. It will not raise any issues in safety and effectiveness.
Aiming laser	5mW, 650nm, InGaAIP	5mW, 650nm, InGaAIP	Same
Laser Delivery	Articulated Arm	Articulated Arm	Same
User Interface	LCD Touch Screen	LCD Touch Screen	Same
Standards met	IEC 60601-1-1IEC 60601-1-2IEC 60601-1-6IEC 60601-2-22IEC 60825-1	IEC 60601-1-1IEC 60601-1-2IEC 60601-1-6IEC 60601-2-22IEC 60825-1	Same

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#401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-2108-2198 / Fax: +82-2-2108-2181

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#401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-2108-2198 / Fax: +82-2-2108-2181

VII. Testing Data

i. Non-Clinical Testing

Non-Clinical Testing was performed for this 510(k) Notification. The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility Testing – The biocompatibility evaluation for the subject device was conducted in accordance with the quidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" as recognized by FDA.
Shelf Life Testing – Expected service life rationale report has been attached in this submission.
트 Software - Verification and validation testing was conducted on the software interface and firmware and the documentation provided is as recommended in the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
. Electromagnetic Compatibility and Electrical Safety - Electromagnetic Compatibility and Electrical Safety testings were conducted on Azure. The following standards were complied with the device:
- Electromagnetic Compatibility: IEC 60601-1-2
- Electrical Safety Testing: IEC 60601-1
- Laser Safety: IEC 60825-1
- Usability: IEC 60601-1-6
. Performance Testing - Performance testing was conducted on Azure according to the following standard:
- IEC 60601-2-22

The subject device passed all tests and successfully met all acceptance criteria and test requirements.

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#401, 402 Woolim e-Biz Center, 28, Digital-ro 33-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-2108-2198 / Fax: +82-2-2108-2181

ii. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices. These types of devices, including the predicated devices, have been on the market for many years with a proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

VIII. Conclusion

Based on the similarities of the subject and predicate device, it is concluded that Azure is substantially equivalent to the predicate device. The summary submitted includes only information that is also covered in the body of the 510(k). It does not include any puffery or unsubstantiated labeling claims, any raw data, any trade secret or confidential commercial information and any patient identification information.

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.