(85 days)
Not Found
No
The device description and summary of performance studies focus on the laser technology and its physical components, with no mention of AI or ML capabilities. The control panel allows the physician to select parameters, indicating manual control rather than automated decision-making based on AI/ML.
Yes
The device is indicated for the treatment of various benign lesions (vascular and pigmented) and tattoo removal, all of which are considered therapeutic applications.
No
Explanation: The device is a Q-Switched Nd:YAG Laser Therapy System used for treatment (tattoo removal, treatment of lesions, incision, ablation, vaporization), not for diagnosing conditions.
No
The device description explicitly states it is a "multi-wavelength, pulsed laser system" and lists hardware components such as "control panel module, main control module, laser power module, temperature and humidity control module and laser module." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The description clearly states that this is a "Q-Switched Nd: YAG Laser Therapy System" used for direct treatment of skin conditions and tattoo removal. It applies laser energy to the body.
- Intended Use: The intended uses listed (tattoo removal, treatment of lesions, incision, ablation, vaporization of soft tissue) are all procedures performed directly on a patient's body.
- Device Description: The components described (control panel, laser module, etc.) are consistent with a therapeutic laser system, not a diagnostic device that analyzes biological samples.
Therefore, this device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota.
532nm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks: Telangiectasias; Spider angioma: Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
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 two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired waveleneth 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 as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device conforms with the following standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity.
- ISO 10993-10:2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
- IEC 60601-1:2005+AMD1:2012 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 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
No clinical study is included in this submission.
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
March 20, 2020
Beijing Lead Beauty S & T Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 Cn
Re: K193609
Trade/Device Name: Q Switched Nd: YAG Laser machine 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 16, 2019 Received: December 26, 2019
Dear Diana 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.
1
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 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 (OS) 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.
Jessica Mavadia-Shukla, Ph.D. Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K193609
Device Name Q Switched Nd:YAG Laser machine
Indications for Use (Describe)
The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota.
532mm: -Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks: Telangiectasias; Spider angioma: Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
| 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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Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K193609
-
- Date of Preparation: 03/10/2020
-
- Sponsor Identification
Beijing Lead Beauty S&T Co., Ltd.
202, No.5 workshop, No.1 caida 3rd Road Nancai Shunyi District, Beijing, China
Establishment Registration Number: Not registered
Contact Person: Jiao Zhang Position: Manager Representative Tel: +86-10-60418096 Fax: +86-10-60418366 Email:13483269828@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
P.O. BOX 120-117, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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Identification of Proposed Device 4.
Trade Name: Q Switched Nd: YAG Laser machine Common Name: Powered Laser Surgical Instrument Model: QLHF-02
Regulatory Information
Classification Name: Powered Laser Surgical Instrument; Classification: II; Product Code: GEX; Regulation Number: 21CFR 878.4810; Review Panel: General& Plastic Surgery;
Indication for Use Statement:
The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm:
-Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota.
532nm:
-Tattoo Removal Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Device Description
The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce two wavelengths, 1064nm and 532nm, to treat different skin color. It consists of control panel module, main control module, laser power module, temperature and humidity control module and laser module. The physician is able to select the desired waveleneth and the related output energy via control panel.
5
-
- Identification of Predicate Device
510(k) Number: K163123 Product Name: O-Switched Nd:YAG Laser Systems Manufacturer: Beijing Sincoheren Science and Technology Development Co., Ltd.
- Identification of Predicate Device
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device conforms with the following standards:
-
ISO 10993-5:2009 Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity.
-
ISO 10993-10:2010 Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization.
-
IEC 60601-1:2005+AMD1:2012 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 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
- A IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
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8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GEX | GEX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Indication for use | The Q-Switched Nd: YAG Laser Therapy System is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: |
1064nm:
-Tattoo Removal
Dark ink: blue and black.
-Treatment of Benign Pigmented Lesions
Nevus of ota.
532nm:
-Tattoo Removal
Light ink: red, Light ink: sky blue and green.
- Treatment of Benign Vascular Lesions
Port wine birthmarks; Telangiectasias;
Spider angioma; Cherry angioma;
Spider nevi.
-Treatment of Benign Pigmented Lesions
Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus. | The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm:
-Tattoo Removal
Dark ink: blue and black.
-Treatment of Benign Pigmented Lesions
Nevus of ota.
532nm:
-Tattoo Removal
Light ink: red, Light ink: sky blue and green.
- Treatment of Benign Vascular Lesions
Port wine birthmarks; Telangiectasias;
Spider angioma; Cherry angioma;
Spider nevi.
-Treatment of Benign Pigmented Lesions
Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus. |
| Lamp Source | Xenon Lamp | Xenon Lamp |
| Energy Source | ND:YAG | ND:YAG |
| Laser Classification | Class 4 | Class 4 |
| | | |
| Laser Wavelength | 1064nm
532nm | 1064nm
532nm |
| Max. Output
Energy | 500mJ for 1064nm
260mJ for 532nm | 500mJ for 1064nm
250mJ for 532nm |
| Spot Size | 2-10mm | 2-10mm |
| Pulse Width | 6ns±1ns | 5ns±1ns or 5ns |
| Repetition Rate | 1-10Hz | 1-5Hz |
| Cooling method | internal distilled water circulating
cooling | internal distilled water circulating
cooling |
| Aiming beam
wavelength | 635nm | 635nm |
| Aiming Beam | 0.1mW-5mW | 0.1mW-5mW |
| Laser output mode | Q-switched pulse | Q-switched pulse |
| Beam delivery | articulated arm light guide | articulated arm light guide |
| Patient contact material | | |
| Light guide arm | Aluminum alloy | Steel, ABS |
| Biocompatibility | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity |
| Sensitization | No evidence of Sensitization | Conforms with ISO 19003 |
| Irritation | No evidence of Irritation | No evidence of Irritation |
| Electrical Safety and EMC | | |
| Electrical Safety | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| EMC | Conforms with IEC 60601-1-2 | Conforms with IEC 60601-1-2 |
| Laser Safety | Conforms with
IEC 60601-2-22,
IEC 60825 | Conforms with
IEC 60601-2-22
IEC 60825 |
Table 1 Comparison of Technology Characteristics
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Electrical safety, EMC, and biocompatibility testing have been conducted on the proposed device, and the results show that the device conforms with the standards. The pulse width, repetition rate, and patient-contact material of the proposed device have differences compared to the predicate device. However, these differences do not substantially affect safety and effectiveness for the indications for use.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.