(265 days)
Not Found
No
The provided 510(k) summary describes a CO2 laser device for soft tissue procedures. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML capabilities. The description focuses on the hardware components and basic user interface.
Yes
The device is intended for medical procedures like incision, excision, ablation, vaporization, and coagulation of human body soft tissues, which are therapeutic interventions.
No
The provided text describes the device's intended use for surgical procedures like incision, excision, ablation, vaporization, and coagulation of soft tissues. These are therapeutic actions, not diagnostic ones (which would involve identifying or characterizing a medical condition).
No
The device description explicitly lists hardware components such as a main body, articulated arm, handpiece, foot switch, power cord, and protective glasses. It also describes a laser operation device using a CO2 medium. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues". These are all surgical procedures performed directly on the patient's body.
- Device Description: The description details a surgical laser system with an articulated arm, handpiece, and foot switch, designed for delivering laser energy to tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The Azure(DS-22CO) is a surgical laser device used for treating soft tissues directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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 10.6µm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human body soft Tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
- IEC 60601-2-22
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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
3
Indications for Use
510(k) Number (if known) K231514
Device Name Azure
Indications for Use (Describe)
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.
| 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
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 10.6µm.
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 ENTERPRISE
CO., Ltd.) | Decision | Explanation |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Finexel | Azure | - | - |
| Manufacturer | SNJ Co., Ltd | DAESHIN ENTERPRISE CO.,
Ltd. | - | - |
| 510K Number | K213557 | K231514 | - | - |
| Classification
Product Code | GEX | GEX | Same | - |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | - |
| Class | Class II | Class II | Same | - |
| Intended Use | Finexel CO2 laser system is
intended for use isn 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. | 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. | Same | - |
| Dimension and
Weight
of Device | 350(W) x 400(L) x 1000(H)
mm
Approx. 50kg | 330(W) x 330(L) x 1060(H)
mm
Approx. 45kg | Different | The dimensions and weight of
the subject device are different
from those of the predicate
device. However, the dimension
and weight difference is only in
physical specification, which will
not raise any issues in safety
and effectiveness. |
| Wavelength | 10,600nm | 10,600nm | Same | - |
| Laser Type
(Source) | CO2 Laser | CO2 Laser | Same | |
| Pulse
Frequency | 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(Zoom
Handpiece) | Slightly
Different | The difference in spot size is very small, approximately 0.2mm, so it will not affect safety or effectiveness. |
| Fluency
(Energy
Density) | 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 60601-1-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-2-22
IEC 60825-1 | IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-2-22
IEC 60825-1 | Same | |
7
#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.
9
#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.