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. 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.

Device Description

The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.

The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

AI/ML Overview

The provided document is a 510(k) summary for the Beijing Sincoheren Science And Technology Development Co.'s Q-Switched Nd:YAG Laser Therapy Systems. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety or effectiveness. Therefore, the document discusses performance data in the context of equivalence rather than proving acceptance criteria for a novel device.

The document does not describe specific acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy) for a new clinical indication or a new type of device. Instead, it relies on demonstrating that the performance characteristics of the proposed device are comparable to or better than those of the predicate device, and that it complies with relevant safety standards.

Here's an analysis of the provided information based on your requested points, framed within the context of a 510(k) submission for substantial equivalence:

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

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device performs at least as well as, or is sufficiently similar to, the predicate device in terms of technical specifications and safety. The reported device performance is presented as a comparison table against the predicate device.

Specification	Predicate device performance	Proposed device performance	Comparison Discussion (Implicit Acceptance)
K number	K133158	--	(Predicate ID)
Product Code	GEX	GEX	Identical
Manufacturer	Beijing Toplaser Technology Co., Ltd	Beijing Sincoheren Science and Technology Development Co., Ltd.	(Different companies, but not a performance metric)
Device name	Nd: YAG Laser System	Q-Switched Nd: YAG Laser Therapy Systems	Similar
Indications for use	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.)	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.)	Identical (Demonstrates equivalence in intended use)
Technology	Q-Switched ND:YAG and KTP Nd: YAG Laser	Q -Switched ND:YAG and KTP Nd: YAG Laser	Identical
Energy Source	Xenon Lamp	Xenon Lamp	Identical
Wavelength (nm)	1064nm and 532nm	1064nm and 532nm	Identical
Aiming beam wavelength	635nm	635nm	Identical
Laser output mode	Q-switched pulse	Q-switched pulse	Identical
Aiming laser output power	<5mw	0.1-5mw	Identical
Maximum Pulse Energy	@1064nm wavelength: 1-1000mJ @532nm wavelength: 50-300mJ	@1064nm wavelength: 500mJ @532nm wavelength: 250mJ	Less than Predicate device, more safe (Acceptable as "safer" or at least equivalent for intended use)
Pulse Duration	6~8ns	5ns±1ns or 5ns	Less Pulse Duration, more peak power, more effective (Acceptable and potentially an improvement)
Repetition Rate	1~10Hz	1-5Hz	Less than Predicate device, more safe (Acceptable as "safer" or at least equivalent for intended use)
Nominal ocular hazard distance	NOHD 2.8km	NOHD 3.3km	Similar (Acceptable)
Spot Size	Adjustable Spot Size 3-9mm(Diameter)	Adjustable Spot Size 2-10mm(Diameter)	Wider adjustable range of spot size than predicate device, more useful (Acceptable and potentially an improvement)
Material	Steel, ABS	Steel, ABS	Identical
Beam delivery	Articulating Arm Light Guide	Articulating Arm Light Guide	Identical
Cooling	Internal distilled water circulating cooling	Internal distilled water circulating cooling	Identical
Anatomical Sites	Skin and subcutaneous tissue	Skin and subcutaneous tissue	Identical

In addition to these direct comparisons, the submission outlines compliance with various safety and performance standards as "performance data" to support the substantial equivalence claim:

Biocompatibility testing: Compliance with ISO 10993-1, including Cytotoxicity, Sensitization, and Irritation tests. (Implicit acceptance criteria: device materials must be biocompatible according to recognized standards for skin and subcutaneous tissue contact < 24 hours).
Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). (Implicit acceptance criteria: device must meet electrical safety and EMC standards).
Performance testing: Compliance with IEC 60825-1 (laser safety). (Implicit acceptance criteria: laser performance must meet safety standards).
Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance for "moderate" level of concern software. (Implicit acceptance criteria: software must be verified and validated according to FDA guidance for its risk level).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical or image-based studies. The performance data presented are primarily technical specifications and compliance with international standards, not data from a clinical test set. Therefore, information on sample size and data provenance for a test set is not applicable to this submission as described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as there is no clinical or image-based "test set" described with ground truth established by experts.

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

Not applicable, as there is no clinical or image-based "test set" requiring adjudication.

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 system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or image interpretation.

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

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

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

Not applicable. For this type of device and submission, the "ground truth" for demonstrating substantial equivalence lies in meeting established engineering standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993-1) and demonstrating comparable basic technical performance to a legally marketed predicate device for the same indications for use. There is no biological "ground truth" involved in the sense of clinical validation of a diagnostic or treatment outcome for this specific 510(k) submission.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set.

In summary:

This 510(k) submission primarily relies on bench testing, compliance with recognized international standards (IEC, ISO), and a direct comparison of technical specifications to a predicate device to demonstrate substantial equivalence. It does not involve experimental clinical studies, human reader studies, or AI algorithm validation data that would typically require "test sets," "ground truth," or "training sets" as you've defined them. The "acceptance criteria" are effectively met by demonstrating that the device is technically comparable or improved (e.g., safer, more effective according to physical principles) for the same intended use as a legally marketed predicate device, and that it adheres to relevant safety and performance standards for medical lasers.

Summary

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Public Health Service

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

February 2, 2017

Beijing Sincoheren Science And Technology Development Co. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co.,ltd. 8-9th Floor, R&d Building, No.26 Qinglan St, Panyu District Guangzhou, 510006 CN

Re: K163123

Trade/Device Name: Q-switched 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: October 31, 2016 Received: November 8, 2016

Dear Mike Gu:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163123

Device Name

O-Switched Nd: YAG Laser Therapy Systems

Indications for Use (Describe)

The Q-Switched Nd: Y AG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Image /page/3/Picture/0 description: The image is a green square with a white design on it. The design appears to be an abstract representation of a letter or symbol, possibly a stylized 'M' or a similar character. The white design contrasts sharply with the green background, making it stand out. The overall impression is that of a logo or emblem.

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

SUBMITTER l.

Beijing Sincoheren Science and Technology Development Co., Ltd.

Address: Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044,

China

Phone: +86-(0)10-57734966

Fax: +86-(0)10-82290050

Primary Contact Person:	Mike Gu
	Regulatory Affairs Manager
	OSMUNDA Medical Device Consulting Co., Ltd
	Tel: (+86) 20-6231 6262
	Fax: (+86) 20-8633 0253
Secondary Contact Person:	Huan Kong
	Regulatory Affairs Engineer
	Beijing Sincoheren Science and Technology Development
	Co., Ltd.
	Tel: (+86) 10-62277431-8009
	Fax: (+86) 10-82290050
Date prepared:	Oct 31, 2016

II. DEVICE

Name of Device:	Q-Switched Nd: YAG Laser Therapy Systems
Common/Usual Name:	YAG Laser Therapy Systems
Classification Names:	Powered Laser Surgical Instrument (21 CFR 878.4810)
Regulation Class:	II
Product Code:	GEX

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Image /page/4/Picture/1 description: The image is a close-up of a green square with a stylized white design. The design features curved lines that resemble a stylized letter or symbol, possibly a monogram or logo. The white lines are thick and bold, contrasting sharply with the green background. The overall impression is a simple yet distinctive graphic element.

PREDICATE DEVICE III.

Nd: YAG Laser System, K133158

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

V. IDICATIONS FOR USE

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.

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Image /page/5/Picture/1 description: The image is a green square with a white abstract design in the center. The design appears to be a stylized representation of a person or figure, with flowing lines suggesting movement or energy. The white figure contrasts sharply against the solid green background, making it the focal point of the image.

VI. TECHNOLOGY

The Q-Switched Nd: YAG Laser Therapy Systems works based on the principles of laser selective photothermy and blasting mechanism of Q-switched laser. Energy from particular wavelength with accurate dose act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanocytes from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enter into lymph circulation system and finally be discharged out of the body.

Specification	Predicate device	Proposed device	Discussion ofDifferences
K number	K133158	--
Product Code	GEX	GEX	Identical
Manufacturer	Beijing Toplaser TechnologyCo., Ltd	Beijing SincoherenScience and TechnologyDevelopment Co., Ltd.
Device name	Nd: YAG Laser System	Q-Switched Nd: YAGLaser Therapy Systems	Similar
Indications for use	1064nm:-Tattoo Removal◇ Dark ink: blue and black-Treatment of Benign Pigmented Lesions◇ Nevus of ota532nm:-Tattoo Removal◇ Light ink: red◇ Light ink: sky blue and green- Treatment of Benign Vascular Lesions◇ Port wine birthmarks; Telangiectasias; Spiderangioma; Cherry angioma; Spider nevi-Treatment of Benign Pigmented Lesions◇ Cafe-au-lait birthmarks; Solar lentiginos; Senilelentiginos; Becker's nevi; Freckles; Nevus spilus.◇		Identical
Technology	Q-Switched ND:YAG and KTPNd: YAG Laser	Q -Switched ND:YAG andKTP Nd: YAG Laser	Identical
Energy Source	Xenon Lamp	Xenon Lamp	Identical
Wavelength (nm)	1064nm and 532nm		Identical
Aiming beamwavelength	635nm		Identical
Specification	Predicate device	Proposed device	Discussion ofDifferences
Laser output mode	Q-switched pulse	Q-switched pulse	Identical
Aiming laseroutput power	<5mw	0.1-5mw	Identical
Maximum PulseEnergy	@1064nm wavelength: 1--~1000mJ@532nm wavelength:50-300mJ	@1064nm wavelength:500mJ@532nm wavelength:250mJ	Less thanPredicatedevice , moresafe
Pulse Duration	6~8ns	5ns±1ns or 5ns	Less PulseDuration, morepeak power,more effective
Repetition Rate	1~10Hz	1-5Hz	Less thanPredicatedevice, moresafe
Nominal ocularhazard distance	NOHD 2.8km	NOHD 3.3km	Similar
Spot Size	Adjustable Spot Size 3-9mm(Diameter)	Adjustable Spot Size 2-10mm(Diameter)	Wideradjustablerange of spotsize thanpredicatedevice, moreuseful
Material	Steel, ABS	Steel, ABS	Identical
Beam delivery	Articulating Arm Light Guide	Articulating Arm Light Guide	Identical
Cooling	Internal distilled watercirculating cooling	Internal distilled watercirculating cooling	Identical
Anatomical Sites	Skin and subcutaneoustissue	Skin and subcutaneoustissue	Identical

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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Image /page/6/Picture/0 description: The image is a close-up of a green square with a white design on it. The design appears to be a stylized representation of a plant or a natural element, possibly a leaf or a sprout. The white design is abstract and consists of curved lines and shapes that create a sense of movement and growth. The green background is a solid, vibrant color that contrasts with the white design, making it stand out. The overall impression is one of nature, growth, and simplicity.

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Q-Switched Nd: YAG Laser Therapy Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

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Image /page/7/Picture/1 description: The image is a green square with a white design on it. The design appears to be an abstract representation of a plant or a tree, with curved lines and shapes that suggest leaves or branches. The white color of the design contrasts with the green background, making it stand out. The overall impression is that of a logo or symbol representing nature, growth, or environmental awareness.

Cytotoxicity
Sensitization
Irritation

The handpiece is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Q-Switched Nd: YAG Laser Therapy Systems. The device complies with the IEC 60601-1, standard for safety and the IEC 60601-1-2 standard for EMC.

Performance testing

Performance testing was conducted on the device according to IEC 60825-1.

Software Verification and Validation Testing

Software verification and validation testing were conducted and 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." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Animal Study

The subject of this premarket submission, Q-Switched Nd: YAG Laser Therapy Systems, does not require animal studies to support substantial equivalence.

Clinical Study

The subject of this premarket submission, Q-Switched Nd: YAG Laser Therapy Systems, did not require clinical studies to support substantial equivalence.

IX. CONCLUSION

The non-clinical data support the safety of the device and the performance testing report demonstrate that the Q-Switched Nd: YAG Laser Therapy Systems should perform as intended in the specified use conditions. Beijing Sincoheren considers the Q-Switched Nd: YAG Laser Therapy Systems to be substantially equivalent to the predicate device and does not raise any new issues of safety or effectiveness.

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.