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.

Device Description

The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called the "ND:YAG Laser" (Model SL-NY602) from Beijing Superlaser Technology Co., Ltd. It seeks to demonstrate substantial equivalence to a predicate device, the "ND YAG Q-switch Laser Therapy Machine" (K161926) from Beijing ADSS Development Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, this document does not present "acceptance criteria" in the traditional sense of specific performance metrics with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it aims to demonstrate substantial equivalence (SE) based on comparative tables for general, technical, and safety aspects. The "acceptance criteria" for this type of submission are that the proposed device is as safe and effective as the predicate device. The reported performance is implicitly the device meeting the described characteristics.

Criterion/Metric	Predicated Device K161926 Performance (Implied Acceptance)	Proposed Device ND:YAG Laser Performance	Remark
General
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	Treatment of benign cutaneous lesions (Warts, Scars, Striae, Psoriasis), benign pigmented lesions (Lentigines, Nevus, Birthmark), and removal of black or blue tattoos.	Treatment of benign cutaneous lesions (Warts, Scars, Striae, Psoriasis), benign pigmented lesions (Lentigines, Nevus, Birthmark), and removal of black or blue tattoos.	SE
Technical
Laser Medium	Nd:YAG	Nd:YAG	SAME
Wavelength	1064 nm, 532 nm	1064 nm, 532 nm	SAME
Output energy	100-1000mJ (1064nm), 50-500mJ (532nm)	100-1000mJ (1064nm), 50-500mJ (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	Disinfect handpiece by 75% medicinal alcohol	Wipe outer surface with 70% alcohol and non-abrasive medical grade anti-bacterial	SIMILAR (both relate to cleaning/disinfection methods for safety)
Laser Class	Class 4	Class 4	SAME
Aiming Beam	Red Laser, <6mW	Red (650nm) laser, ≤5mW	SAME
Safety
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Comply with IEC 60601-2-22, IEC 60825	SE

2. Sample Size used for the Test Set and the Data Provenance

The submission does not rely on a test set of patient data for clinical performance evaluation. Instead, it relies on demonstrating equivalence through comparison to a legally marketed predicate device and non-clinical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. No ground truth was established by experts for a clinical test set in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in this submission.

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

Not applicable. This is a laser device, not an AI-assisted diagnostic or imaging system, so an MRMC study is not relevant.

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

Not applicable. This is a laser device, not an algorithm.

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

Not applicable. Clinical ground truth (e.g., pathology, outcomes data) was not used in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence relied on established safety and performance standards for similar laser devices and the characteristics of the predicate device.

8. The sample size for the training set

Not applicable. This is a hardware medical device (laser system), not a machine learning 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 type of device.

Summary

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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

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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)

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

1. Date of Preparation 04/10/2020
1. 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
1. 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
1. 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

1. Device Description
  The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

1. 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.

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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 nm532 nm	1064 nm532 nm	SAME
Output energy	100-1000mJ for 1064nm50-500mJ for 532nm	100-1000mJ for 1064nm50-500mJ for 532nm	SAME
Max. EnergyDensity	31.8J/cm215.9 J/cm2	31.8J/cm215.9 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 bewiped clean with a soft cotton clothswabbed in 70% alcohol and a non-abrasive medical grade anti-bacterialis recommended. Be careful not to spillany liquids on the unit.	Disinfect the handpiece before andafter every treatment by 75%medicinal alcohol	SIMILAR
Laser Class	Class 4	Class 4	SAME
Aiming Beam	Red (650nm) laser, ≤5mW	Red Laser, <6mW	SAME

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Item	Proposed Device	Predicate Device K161925	Remark
EMC, Electrical and Laser Safety
Electrical Safety	Comply with IEC 60601-1, IEC60601-2-22	Comply with IEC 60601-1, IEC60601-2-22	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Laser Safety	Comply with IEC 60601-2-22, IEC 60825	Comply with IEC 60601-2-22, IEC 60825	SE

Tab 3 Safety Comparison

Non-Clinical Testing 9.

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:

A 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;
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.

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.