(191 days)
No
The device description and performance studies focus on the laser technology and its safety/performance standards, with no mention of AI or ML. The control is described as microprocessor-based, allowing the physician to select parameters.
Yes
The device is indicated for the treatment of numerous medical conditions, including removal of benign pigmented lesions, vascular lesions, and treatment of acne scars and wrinkles. These applications address conditions and aim to restore function.
No
The device is indicated for treatment procedures like incision, ablation, vaporization, and removal/treatment of various lesions and tattoos, not for diagnosing conditions.
No
The device description explicitly states it is a "multi-wavelength, pulsed laser system" and lists hardware components such as a power supply module, microprocessor control module, laser treatment handpiece module, operation display module, and cooling system module. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes procedures performed on the patient's body (incision, ablation, vaporization of soft tissues, tattoo removal, lesion removal, hair removal, skin resurfacing). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed for direct application to the skin and soft tissues. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on safety standards for medical electrical equipment and biological evaluation of devices that come into contact with the body, which are typical for devices used directly on patients. There are no mentions of studies related to the accuracy or performance of analyzing biological samples.
In summary, the device is a therapeutic laser system used for various dermatological and surgical procedures performed directly on the patient, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The device is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm wavelength:
-Tattoo removal: light ink(red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
Product codes
GEX
Device Description
The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce 1064nm and 532nm two different laser wavelengths to treat the different color skin. It consists of power supply module, microprocessor control module, laser treatment handpiece module, operation display module and cooling system module. The physician is able to select the desired wavelength and the related output energy via control panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following documents:
- IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance:
- IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment;
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- Software Validation & Verification Test, documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Additionally, Bench Testing was conducted to verify the performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Beijing Kes Biology Technology Co., Ltd. % Daina Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box. 120-119 Shanghai, 200120 Cn
June 24, 2020
Re: K193477
Trade/Device Name: Nd:YAG Laser Therapy Systems 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: December 4, 2019 Received: December 16, 2019
Dear Daina Hong:
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 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
1
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 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.
Neil R.P. Ogden, MS Assistant Director 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
2
Indications for Use
510(k) Number (if known) K193477
Device Name Nd:YAG Laser Therapy Systems
The device is indicated for the incision, ablation, vaporization of soft tissues for general dermatology,
dermatologic and general surgical procedures for coagulation and hemostasis.
532nm wavelength:
-Tattoo removal: light ink(red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
- -Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation.
- -Treatment of Common Nevi
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
The assigned 510(k) Number: K193477
- Date of Preparation: 06/24/2020 1.
- Establishment Registration Number: 3009444646 2.
| 3. Applicant | |
|---|---|
| Name: | BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. |
| Address: | No.15, Zone 2, Mafang Industrial Park, PingguyuanZhongguancun Science And |
| Technology Park Pinggu District, Beijing CHINA 101204 | |
| Contact Person: | Wei Meng Meng |
| Telephone: | +86-10-60998698 |
| Fax: | +86-10-61227575 |
| Email: | weimengmeng@keslaser.com |
Submission Correspondent 4.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
-
- Identification of the Proposed Device
| Trade Name: | ND:YAG Laser Therapy Systems |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Model(s): | MED-810A |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification: | II |
| Product Code: | GEX |
| Regulation Number: | 21 CFR 878.4810 |
| Review Panel: | General& Plastic Surgery |
-
- Identification of Predicate Device 510(k) Number: K173038 Product Name: CuRAS Nd: YAG Laser
-
- Device Description
The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce 1064nm and 532nm two different laser wavelengths to treat the different color skin. It consists of power supply module, microprocessor control module, laser treatment handpiece module, operation display module and cooling system module. The physician is able to select the desired wavelength and the related output energy via control panel.
-
- Indications for Use
The device is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm wavelength:
- Indications for Use
-Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
4
- -Removal of Epidermal Benign Pigmented Lesions
- -Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
- -Treatment of Lentigines
- -Treatment of Cafe-Au-Lait
- -Treatment of Seborrheic Keratoses
- -Treatment of Post Inflammatory Hyper-Pigmentation
- -Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota -
-Removal or lightening of unwanted hair with or without adjuvant preparation.
-Treatment of Common Nevi -
-Skin resurfacing procedures for the treatment of acne scars and wrinkle
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device K173038 |
|---|---|---|
| Product code | GEX | GEX |
| Class | II | II |
| Indications for use | The device is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. |
532nm wavelength:
-Tattoo removal: light ink(red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Benign Pigmented Lesions
-Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation. | The CuRAS Nd; YAG laser systems indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm wavelength:
-Tattoo removal: light ink(red, tan, purple, orange, skyblue, green)
-Removal of Epidermal Pigmented Lesions
-Removal of Minor Vascular Lesions including but not limited to telangiectasias
-Treatment of Lentigines
-Treatment of Cafe-Au-Lait
-Treatment of Seborrheic Keratoses
-Treatment of Post Inflammatory Hyper-Pigmentation
-Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
-Tattoo removal: dark ink (black, blue and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted hair with or without adjuvant preparation. |
5
| -Treatment of Common Nevi | -Treatment of Common Nevi | |
|---|---|---|
| -Skin resurfacing procedures for the | -Skin resurfacing procedures for the | |
| treatment of acne scars and wrinkle | treatment of acne scars and wrinkle | |
| Energy Source | Xenon Lamp | Xenon Lamp |
| Wavelength (nm) | 1064nm and 532nm | 1064nm and 532nm |
| Aiming beam wavelength | 635nm | 635nm |
| Aiming laser output power | 5mW | 5mW |
| Laser output mode | Q-switched pulse | Q-switched pulse |
| Maximum pulse energy | @1064nm wavelength:1600mJ | |
| @532nm wavelength:400mJ | @1064nm wavelength:1600mJ | |
| @532nm wavelength:400mJ | ||
| Pulse Duration | 5-10ns | 5~20ns |
| Spot Size | 2mm-10mm | 2mm-10mm |
| Fluence range | 1064nm | |
| 0.4-51.0 J/cm2 | ||
| 532nm | ||
| 0.4-12.7 J/cm2 | Unknown | |
| Repetition rate | 1-6Hz | 1-15Hz |
| Patient contact material | Aluminum alloy, ABS | Unknown |
| Biocompatibility | ||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity |
| Sensitization | No evidence of Sensitization | No evidence of sensitization |
| Irritation | No evidence of Irritation | No evidence of irritation |
| Electrical Safety and EMC | ||
| Electrical Safety | Comply with | Comply with |
| IEC 60601-1 | IEC 60601-1 | |
| IEC 60601-2-22, | IEC 60601-2-22, | |
| EMC | Comply with | Comply with |
| IEC 60601-1-2 | IEC 60601-1-2 |
10. Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following documents:
- ▲ IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance:
- A IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment;
- ▲ IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]
- A ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- A Software Validation & Verification Test, documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
6
Additionally, Bench Testing was conducted to verify the performance.
-
- Clinical Testing
No clinical study is included in this submission.
- Clinical Testing
-
- Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.
- Conclusion