The Q-Switched Nd: Y AG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, incision, ablation, vaporization of soft tissue for general dermatology as follows:

532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):

Removal of light ink (red, sky blue, green, purple, and orange) tattoo
Treatment of benign vascular lesions including, but not limited to: telangiectasias,
Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation

1064nm wavelength:

Removal dark ink (black, blue and brown) tattoo
Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
Removal or lightening of unwanted hair with or without adjuvant preparation
Skin resurfacing procedures for the treatment of acne scars and wrinkles.

Device Description

The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system,foot switch and others accessories.

The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm.

The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) summary for the Q-Switched Nd: YAG Laser System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based diagnostic AI.

Here's why and what the document does discuss:

Device Type: The document describes a Q-Switched Nd: YAG Laser System, which is a physical laser device used for various dermatological and surgical applications (tattoo removal, pigmented lesions, etc.). It is not an artificial intelligence (AI) software or diagnostic imaging device.
"Acceptance Criteria" in this context: For a physical medical device like a laser, "acceptance criteria" primarily refer to meeting technical specifications (e.g., laser power output accuracy, wavelength precision, pulse duration, electrical safety standards, electromagnetic compatibility). These are shown in the "VII Non-Clinical Testing" section by compliance with IEC standards.
No AI Study: Since this is not an AI/software device, there is no discussion of:
- A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets or data provenance for AI validation.
- Number of experts, qualifications, or adjudication methods for AI ground truth.
- MRMC studies for human reader improvement with AI assistance.
- Standalone algorithm performance.
- Ground truth types like pathology or outcomes for diagnostic AI.
- Training set details for an AI model.

The document explicitly states under "VIII Clinical Testing": "It is not applicable." This means that for the purposes of this 510(k) submission and establishing substantial equivalence for this laser device, a formal clinical study (which would be where you'd typically find performance data against clinical endpoints or, in the case of diagnostic AI, against expert ground truth) was not required by the FDA. The submission relies on non-clinical testing showing compliance with recognized standards and a comparison of technological characteristics to a predicate device.

Therefore, I cannot extract the information you requested based on the provided text. The questions are highly relevant for diagnostic AI medical devices, but the provided document describes a therapeutic laser device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the word "ADMINISTRATION" in a smaller font size below "U.S. FOOD & DRUG".

Shanghai Apolo Medical Technology Co., Ltd. % Felix Li Regulatory Affairs 4F, Building A, No. 388 Yindu Road Xuhui District Shanghai, 200231 China

June 17, 2019

Re: K190936

Trade/Device Name: Q-Switched Nd: Y AG Laser System 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: April 4, 2019 Received: April 10, 2019

Dear Felix Li:

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.

Neil R.P. Ogden, MS Acting Assistant Director, THT4A3: Light Based Devices Team 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) K190936

Device Name

Q-Switched Nd: YAG Laser Systems

Indications for Use (Describe)

532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):

Removal of light ink (red, sky blue, green, purple, and orange) tattoo
Treatment of benign vascular lesions including, but not limited to: telangiectasias,
Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation

1064nm wavelength:

Removal dark ink (black, blue and brown) tattoo
Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
Removal or lightening of unwanted hair with or without adjuvant preparation
Skin resurfacing procedures for the treatment of acne scars and wrinkles.

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

I Submitter

Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231,China

Establishment Registration Number: 3007120647

Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn

II Proposed Device

Trade Name of Device:	Q-Switched Nd: YAG Laser System
Common name:	Powered Laser Surgical Instrument
Regulation Number:	21 CFR 878.4810
Regulatory Class:	Class II
Product code:	GEX
Review Panel:	General & Plastic Surgery

III Predicate Devices

510(k) Number:	K113588
Trade name:	SPECTRA Q-Switched Nd:YAG LaserSystem with Dye Handpieces
Common name:	Powered Laser Surgical Instrument
Classification:	Class II
Product Code:	GEX
Manufacturer	Lutronic Corporation

IV Device description

The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator,

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articulated arm, laser power supply, cooling system, display and control system,foot switch and others accessories.

The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.

V Indication for use

The Q-Switched Nd: YAG Laser System is intended 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:

532nm wavelength (nominal delivered energy of 585nm and 650nm with optional dye handpiece):

· Removal of light ink (red. sky blue, green, purple, and orange) tattoo,
· Treatment of benign vascular lesions including, but not limited to: telangiectasias,
· Treatment of benign epidermal pigmented lesions including. but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses,
· Treatment of Post Inflammatory Hyper-Pigmentation.

1064nm wavelength:

· Removal dark ink (black, blue and brown) tattoo,
· Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma,
· Removal or lightening of unwanted hair with or without adjuvant preparation,
· Skin resurfacing procedures for the treatment of acne scars and wrinkles.

VI Comparison of technological characteristics with the predicate devices

A table comparing the key features of the proposed and predicate devices is provided below.

Item	Subject device	Predicate device(K113588)
Product name	Q-Switched Nd: YAG Laser System	SPECTRA Q-SwitchedNd:YAG Laser System withDye Handpiece
Product Code	GEX	GEX

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RegulationNo.	21 CFR 878.4810	21 CFR 878.4810
Class	Class II	Class II
Indication foruse	The Q-Switched Nd: YAG LaserSystem is intended for use in tattooremoval, treatment of benignvascular lesions, treatment of benignpigmented lesions, incision, excision,ablation, vaporization of soft tissuefor general dermatology as follows:	The SPECTRA Laser System isindicated for the Incision,excision, ablation, vaporizationof soft tissues for generaldermatology, dermatologic andgeneral surgical procedure forcoagulation and hemostasis.
	532nm wavelength (nominal
	delivered energy of 585nm and	532nm Wavelength (normal
	650nm with optional dye	delivered energy of 585nm and
	handpiece):	650nm with optional dyehandpieces):
	Removal of light ink (red, skyblue, green, purple, and orange)tattoo Treatment of benign vascularlesions including, but not limitedto: telangiectasias, Treatment of benign epidermalpigmented lesions including, butnot limited to: cafe-au-lait, solarlentiginos, senile lentiginos,Becher's, nevi Freckles, Nevusspilus, Seborrheic Keratoses Treatment of Post InflammatoryHyper-Pigmentation	Tattoo removal: light ink(red, tan, purple, orange,sky blue, green) Removal of EpidermalPigment Lesions Removal of MinorVascular Lesions includingbut not limited totelangiectasias Treatment of Lentigines Treatment of Café-Au-lait Treatment of PostInflammatoryHyper-Pigmentation Treatment of Becker'sNevi, Freckles and NeviSpilus
	1064nm wavelength:	1064nm Wavelength
	Removal dark ink (black, blueand brown) tattoo Removal of benign dermalpigmented lesions including, butnot limited to: Nevus of OTA,Common Nevi, and Melasma.	Tattoo removal: dark ink(black, blue and brown) Removal of EpidermalPigment Lesions Removal of Nevus of Ota
	Removal or lightening of unwanted hair with or without adjuvant preparation Skin resurfacing procedures for the treatment of acne scars and wrinkles	Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedure for the treatment of acne scars and wrinkle Treatment of melasma.
Anatomical site	Skin and subcutaneous tissue	Skin and subcutaneous tissue
Technology	Q-Switched Nd: YAG amd KTP Nd:YAG Laser	Q-Switched Nd: YAG amd KTP Nd:YAG Laser
Pump lamp source	Xenon lamp	Xenon lamp
Wavelength (nm)	1064nm/532nm	1064nm/532nm
Aiming beam wavelength	650nm	655nm
Laser output mode	Q-Switched pulse	Q-Switched pulse
Maximum pulse energy	1064nm wavelength: 1200mJ;532nm wavelength:500mJSPT mode: 1400mJ	1064nm wavelength: 1200mJ;532nm wavelength:400mJSPT mode: 1500mJ
Pulse durationRepetition rate	4~6ns (Q-Switched mode) /300μs (SPT mode)Max,10Hz	5~10nsQ-Switched mode )/300µs (Spectra mode)Max,10Hz
Nominal ocular hazard distance	2580m	unknown
Spot size	Adjustable spot size 1~10mm	3, 4, 5, 6, 7, 8mm/1, 2, 3, 4, 5, 6, 7mm (option)
Beam delivery	Articulated arm light guide	Articulated arm light guide
Cooling system	Water cooling, forced-air cooling, Copper Radiator	Closed internal circulating water cooling, outer circulation

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		strong wind cooling
Systemdimension	HS-290K:11.8"(W)×32.7"(L)×34.6"(H)HS-290EK:11.8"(W)×29.5"(L)×34.6"(H)	11.6"(W)×25.8"(L)×66.93"(H)
Systemweight	HS-290K: 176.4lbsHS-290EK: 167.6 lbs	194lbs
Electricalrequirements	AC 110V, 50/60Hz	AC 220-230V, 50/60Hz
Maximumpower	200MW	240MW

VII Non-Clinical Testing

A battery of tests were performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

Electrical safety and electromagnetic compatibility

IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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

IEC 60601-2-22:2013 Medical electrical equipment - Part 2-22: Particular requirements for the 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

VIII Clinical Testing

It is not applicable.

IX Conclusion

The proposed device, Q-Switched Nd: YAG Laser System has the intended use as the predicate device. It presents similar technological characteristics as the predicate device including the laser type, wavelengths, device design, pulse width, frequency, spot sizes. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed 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.