(119 days)
Not Found
No
The summary describes a laser therapy machine and its intended uses, with no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
Yes
The device description and intended use clearly state that it is for the "treatment" of various medical conditions, indicating a therapeutic purpose.
No
The device description indicates it is used for "treatment" of various conditions and tattoo removal, not for diagnosing them.
No
The device description explicitly states it is a "laser system" and a "Laser Therapy Machine," indicating it is a hardware device that delivers laser energy. The performance studies also include testing related to electrical safety and laser safety standards, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a laser system used for the direct treatment of various skin conditions and tattoo removal. It interacts directly with the patient's body, not with a specimen taken from the body.
The description clearly indicates a therapeutic device used for external applications on the skin.
N/A
Intended Use / Indications for Use
The ND:YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and the removal of black or blue tattoos.
Product codes
GEX
Device Description
The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.
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
Prescription Use, hospital
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
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 following tests were conducted:
- 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 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 compatibility-Requirements and tests.
- Software Validation & Verification Test
- Bench Testing to verify the performance
No clinical study is included in this submission.
Key Metrics
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
April 13, 2020
Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co. Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, 102401 CN
Re: K193464
Trade/Device Name: ND:YAG Laser 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: March 13, 2020 Received: March 16, 2020
Dear Ray Wang:
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
1
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,
Colin Kejing Chen 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193464
Device Name ND:YAG Laser
Indications for Use (Describe)
The ND: YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and the removal of black or blue tattoos.
| 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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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
The assigned 510(k) Number: K193464
-
- Date of Preparation 04/10/2020
-
- Applicant Name: Beijing Superlaser Technology Co., Ltd. Address: No.2, Zhongfu Street, Economic and Technological Industrial zone, Xihongmen Tower, Daxing District, Beijing, China. Contact Person: Shi Shuang Position: Registration Specialist Telephone: 86-10-81284899 ext. 806 86-10-81284899 Fax: Email: 672257488@qq.com
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- Submission Correspondent Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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- Identification of the Proposed Device
| Trade Name: | ND:YAG Laser |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Model(s): | SL-NY602 |
| Classification Name: | Powered Laser Surgical Instrument |
| Classification: | II |
| Product Code: | GEX |
| Regulation Number: | 21 CFR 878.4810 |
| Review Panel: | General& Plastic Surgery |
- Identification of Predicate Device న్.
| 510(k) Number: | K161926 |
|---|---|
| Product Name: | ND YAG Q-switch Laser Therapy Machine |
| Manufacturer: | Beijing ADSS Development Co., Ltd |
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- Device Description
The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.
- Device Description
The device is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. It is for prescription use only.
-
- Indications for Use
The ND:YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.
- Indications for Use
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8. Substantially Equivalent (SE) Comparison
Tab 1 General Comparison
| ITEM | Proposed Device | Predicate Device K161926 | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Where used | hospital | hospital | SE |
| Intended Use | The ND:YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. | The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: Benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; Benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. | SE |
Tab 2 Technical Comparison
| ITEM | Proposed Device | Predicate Device K161926 | Remark |
|---|---|---|---|
| Laser Medium | Nd:YAG | Nd:YAG | SAME |
| wavelength | 1064 nm | ||
| 532 nm | 1064 nm | ||
| 532 nm | SAME | ||
| Output energy | 100-1000mJ for 1064nm | ||
| 50-500mJ for 532nm | 100-1000mJ for 1064nm | ||
| 50-500mJ for 532nm | SAME | ||
| Max. Energy | |||
| Density | 31.8J/cm2 | ||
| 15.9 J/cm2 | 31.8J/cm2 | ||
| 15.9 J/cm2 | SAME | ||
| Spot Size | 2-10mm | 2-10mm | SAME |
| Pulse Width | 5ns-8ns | 5ns-8ns | DIFFERENT |
| Frequency | 1-10 Hz | 1-10 Hz | SAME |
| Disinfection | The outer surface of the system may be | ||
| wiped clean with a soft cotton cloth | |||
| swabbed in 70% alcohol and a non- | |||
| abrasive medical grade anti-bacterial | |||
| is recommended. Be careful not to spill | |||
| any liquids on the unit. | Disinfect the handpiece before and | ||
| after every treatment by 75% | |||
| medicinal alcohol | SIMILAR | ||
| Laser Class | Class 4 | Class 4 | SAME |
| Aiming Beam | Red (650nm) laser, ≤5mW | Red Laser, IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic and Diagnostic Laser Equipment; |
- A 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 compatibility-Requirements and tests.
- ▲ Software Validation & Verification Test
- ▲ Bench Testing to verify the performance
10. Clinical Testing
No clinical study is included in this submission.
11. Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.