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.

Device Description

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

There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or comprehensive study results for a new AI/software system. Therefore, much of the requested information regarding AI-specific criteria, studies, and ground truth establishment is not applicable or available in this document.

However, I can extract the relevant information from the provided text as it pertains to the device's performance claims and the studies conducted to support its substantial equivalence.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the typical sense for a new AI/software device. Instead, it compares the proposed device's specifications and performance to a predicate device to demonstrate "substantial equivalence" (SE). The "reported device performance" is essentially the detailed specifications of the proposed device as presented for comparison.

Criterion Type	Acceptance Criteria (Predicate Device K072536)	Reported Device Performance (Proposed Device)	Remark
Regulatory Information
Product Code	GEX	GEX	SE
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SE
Class	2	2	SE
Intended Use	Benign cutaneous lesions, benign pigmented lesions, tattoo removal, vascular lesions, non-ablative treatment of facial wrinkles, laser skin resurfacing, reduction of red pigmentation in scars, use on all skin types.	Benign cutaneous lesions (Warts, Scars, Striae, Psoriasis); benign pigmented lesions (Lentigines, nevus, birthmark); removal of black or blue tattoos.	SE
Performance Comparison
Laser Medium	Nd:YAG	Nd:YAG	SE
Wavelength	1064 nm, 532 nm	1064 nm, 532 nm	SE
Output energy	400-1200mJ	100-1000mJ for 1064nm, 50-500mJ for 532nm	SE
Max. Energy Density	16.9 J/cm²	31.8 J/cm² (for 1064nm), 15.9 J/cm² (for 532nm)	Analysis
Spot Size	3, 5 mm	2-10mm	Analysis
Pulse Width	20 ns	5ns-8ns	Analysis
Repetition Rate	1, 2, 4 Hz	1-10 Hz	Analysis
Disinfection	---	Disinfect the handpiece before and after every treatment by 75% medicinal alcohol	Analysis
Laser Class	Class 4	Class 4	SE
Cooling method for treated skin	N.A.	N.A.	SE
Aiming Beam	N.A.	Red Laser, < 6mW	Analysis
Safety Comparison
Patient Contact Materials	Treatment Probe (Stainless Steel)	Treatment Probe (Stainless Steel)	SE
Cytotoxicity	Comply with ISO 10993-1	No Cytotoxicity
Sensitization	---	No evidence of sensitization	SE
Irritation	---	No evidence of irritation
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

No clinical test set or data provenance is mentioned as this device is not an AI/software product requiring such a test set. This submission relies on non-clinical testing to demonstrate substantial equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No ground truth establishment by experts for a test set is described, as the device is not an AI/software product that requires diagnostic performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method is described.

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 device is a laser therapy machine, not an AI-assisted diagnostic tool, 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 device is a laser therapy machine, not an algorithm.

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

Not applicable. The equivalence is based on technical specifications and safety standards rather than diagnostic ground truth.

8. The sample size for the training set

Not applicable. No training set is mentioned for this device.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth establishment for a training set is described.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The study primarily consisted of non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent (SE) to the predicate device (Harmony XL Multiple Application Platform, K072564).

The tests conducted focused on:

Compliance with International Standards:
- IEC 60601-1:2012 (Medical Electrical Equipment - Basic Safety and Essential Performance)
- IEC 60601-2-22:2007 (Medical Electrical Equipment - Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment)
- IEC 60825-1:2007 (Safety of laser products - Equipment classification and requirements)
- IEC 60601-1-2:2007 (Electromagnetic compatibility)
Biocompatibility:
- ISO 10993-5:2009 (Tests for Vitro cytotoxicity)
- ISO 10993-10:2002/Amd. 1: 2006 (Test for irritation and delay-type hypersensitivity)
Specific Device Performance Tests:
- Performance Testing for Spot Size Accuracy.
- Thermal Energy Distribution Test (to determine the difference for thermal energy distribution of proposed device with predicate device).

No clinical study was included in this submission. The approach relied on demonstrating that the proposed device performed "as safe, as effective, and performs as well as the legally marketed predicate device" based on direct technical and safety comparisons and adherence to established medical device standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2017

Beijing Adss Development Co., Ltd % Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju No. 25 Banbidian Rd. LiYuan Town, Tongzhou District, Beijing, 101121 China

Re: K161926 Trade/Device Name: Nd Yag Q-switch Laser Therapy 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: January 18, 2017 Received: January 23, 2017

Dear Mr. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation 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) K161926

Device Name ND YAG O-switch Laser Therapy Machine

Indications for Use (Describe)

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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Tab #3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K161926

1. Date of Preparation
  02/16/2017
Sponsor 2.

Beijing ADSS Development Co., Ltd

F6, Xiandao Bldg., Jinyuan Rd. 36, Daxing Economic Development zone, Beijing, China, 102628

Establishment Registration Number: Not yet registered or the Number Contact Person: Gao Yurong Position: sales manager Tel: 86-10-83625120 Fax:86-10-83625121 Email: gyr@adss.com.cn

Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

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1. Identification of Proposed Device
  Trade Name: ND YAG Q-switch Laser Therapy Machine Common Name: Powered Laser Surgical Instrument Model(s): FG 2010, FG 2010-B, FG 2010-C

Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;

Intended Use:

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

There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations. The detailed difference shown as following:

Model	FG2010	FG2010-B	FG2010-C
Size	860×310×830mm	800×320×920mm	830×320×830mm
Weight	60kg	65kg	60kg

Table 1 The Difference of Models

Table 2 Main Components introduction
--------------------------------------	--	--

Component name	Function
Main unit	Main Interface
Articulated Arm	Articulated arm for holding of Treatment Probe
Treatment Probe	Laser Deliver
Foot Pedal	control pulse light output

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1. Identification of Predicate Device
  Predicate Device: 510(k) Number K072564

Predicate Device Name Harmony XL Multiple Application Platform

Manufacturer

Alma Laser, Ltd

1. Non-Clinical Test
  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 standards:
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
Performance Testing for Spot Size Accuracy.
Thermal Energy Distribution Test: determine the difference for thermal energy distribution of proposed device with predicate device.
1. Clinical Test

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device	Remark
Product Code	GEX	GEX	SE
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SE
Class	2	2	SE
Intended Use	The ND YAG Q-switch Laser TherapyMachine is indicated for the treatment of:benign cutaneous lesions, such as Warts,Scars, Striae and Psoriasis; benignpigmented lesions, such as Lentigines,nevus, and birthmark; and the removal ofblack or blue tattoos.	The 1064 nm Long Pulsed and Q-switchedNd:YAG Laser Module HandpiecesThe 1064 nm Nd:YAG Laser Modulehandpiece (Long Pulsed and Q-switchedwith and without contact-cooling) areindicated for treatment and clearance ofBenign vascular lesions such as, butnot limited to treatment of: Port wine stains Hemangiomas Warts Superficial and deeptelangiectasias (venulectasias) Reticular veins (0.1-4.0 mmdia.) of the leg Rosacea Venus lake Leg veins Spider veins Angiomas Benign cutaneous lesions, such as,but not limited to : Warts Scars Striae Psoriasis Benign pigmented lesions such as,but not limited to: Lentigos (age spots) Solar lentigos (sun spots) Café-au- lait birthmarks Seborrheic keratoses Nevi and nevus of Ota Chloasma Verrucae	SE

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	> Skin tage
	> Keratoses
	> The removal of black, blue or
	green tattoos (significant
	reduction in the intensity of
	black and /or blue tattoos)
	> Plaques
•	Pigmented lesions to reduce lesion
	size, for patients with lesions that
	would potentially benefit from
	aggressive treatment, and for patients
	with lesions that have not responded
	to other laser treatments.
•	The non-ablative treatment of facial
	wrinkles, such as, but not limited to:
	> Periocular wrinkles
	> Perioral wrinkles
•	Laser skin resurfacing procedures for
	the treatment of:
	> Acne scars
	> Wrinkles
•	Reduction of red pigmentation in
	hypertrophic and keloid scars where
	vascularity is an integral part of the
	scar.
	Indicated for use on all skin types
	(Fitzpatrick I-VI), including tanned skin

Table 4 Performance Comparison

ITEM	Proposed Device	Predicate Device 2K072536	Remark
Laser Medium	Nd:YAG	Nd:YAG	SE
wavelength	1064 nm532 nm	1064 nm532 nm	SE
Output energy	100-1000mJ for 1064nm50-500mJ for 532nm	400-1200mJ	SE
Max.EnergyDensity	31.8J/cm²15.9 J/cm²	16.9 J/cm²	SE
Spot Size	2-10mm	3, 5 mm	Analysis

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Pulse Width	5ns-8ns	20 ns	Analysis
Repetition Rate	1-10 Hz	1, 2, 4 Hz	Analysis
Disinfection	Disinfect the handpiece before andafter every treatment by 75%medicinal alcohol	---	Analysis
Laser Class	Class 4	Class 4	SE
Coolingmethodfor treated skinarea	N.A.	N.A.	SE
Aiming Beam	Red Laser, < 6mW	N.A	Analysis

Table 5 Safety Comparison

Item	Proposed Device	Predicate Device	Remark
		K072536
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Treatment Probe (Stainless Steel)	Treatment Probe (Stainless Steel)	SE
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993-1
Sensitization	No evidence of sensitization		SE
Irritation	No evidence of irritation
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, IEC60825	Comply with IEC 60601-2-22, IEC 60825	SE

Analysis for difference

The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

10. 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.

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.