The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:

Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Device Description

The PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond 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. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.

AI/ML Overview

The provided text is a 510(k) summary for the PicoSecond Nd: YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. Crucially, it explicitly states "Clinical Testing: It is not applicable." This means that there was no clinical study conducted to prove the device's performance against specific acceptance criteria.

Therefore, I cannot provide the information requested in the prompt, as the provided document indicates that no such study was performed or needed for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
Sample sized used for the test set and the data provenance: No test set due to the absence of a clinical study.
Number of experts used to establish the ground truth... and qualifications: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "It is not applicable."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical laser system, not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable, as this refers to training data for AI/ML models, which is not relevant here.
How the ground truth for the training set was established: Not applicable.

The document focuses solely on non-clinical testing to demonstrate substantial equivalence, specifically mentioning:

Electrical safety and electromagnetic compatibility: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
Performance characteristics: Implied through comparison of technical specifications with predicate devices (e.g., wavelengths, pulse energy, pulse duration, repetition rate, spot size). The conclusion states that the maximum pulse energy of the proposed device, while higher than one predicate and lower than another, "can be considered that the propose device can achieve its intended use and is safety." This is a declarative statement based on engineering comparison and non-clinical safety/performance tests, not clinical trial data.

In summary, for this particular 510(k) submission, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" were based on a comparison to legally marketed predicate devices and a battery of non-clinical, bench and lab-based engineering tests to ensure safety and performance equivalence, rather than a clinical trial.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

Shanghai Apolo Medical Technology Co., Ltd. % Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705 , Building 1, West Guangzhong Road 555, Jingan District Shanghai, 200071 Cn

Re: K200116

Trade/Device Name: PicoSecond Nd: YAG 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 16, 2020 Received: April 27, 2020

Dear Claire Zhang:

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.

{1}------------------------------------------------

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 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

Re: K200116

Dear Claire Zhang:

{3}------------------------------------------------

Sincerely.

Enclosure

{4}------------------------------------------------

K200116-510(k) summary

l Submitter

Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231, China Preparation date: Apr. 09, 2020

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:	PicoSecond 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:	K191685
Trade name:	PicoWay Laser System
Common name:	Laser Surgical Instrument
Classification:	Class II
Product Code:	GEX
Manufacturer	Candela Corporation

510(k) Number:	K173700
Trade name:	Picoplus laser system
Common name:	Laser Surgical Instrument
Classification:	Class II
Product Code:	GEX

{5}------------------------------------------------

Lutronic Corporation Manufacturer

IV Device description

The PicoSecond 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. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.

V Indication for use

Indication for use

The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

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 (K191685)	Predicate device (K173700)
Product name	PicoSecond Nd:YAG Laser System	PicoWay Laser System	Picoplus laser system
Product Code	GEX	GEX	GEX

{6}------------------------------------------------

RegulationNo.	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Class	Class II	Class II	Class II
Indicationfor use	The PicoSecond Nd:YAG Laser Systemis intended for use insurgical andaesthetic applicationin the medicaldermatology andgeneral and plasticsurgery as follows:1064nmwavelength:• Removal oftattoos on allskin type(Fitzpatrick skintypes I-VI) withthe followingtattoo colors:black, brown,green, blue andpurple.• Treatment ofbenignpigmentedlesions onFitzpatrick skintypes I-IV.532nm wavelength:• Removal of	The PicoWay lasersystem is indicatedfor the following atthe specifiedwavelength532 nm: Removal oftattoos for Fitzpatrickskin types I - III totreat the followingtattoo colors: red,yellow and orange.730 nm: Removal oftattoos for Fitzpatrickskin types II - IV totreat the followingtattoo colors: greenand blue.785 nm: Removal oftattoos for Fitzpatrickskin types II - IV totreat the followingtattoo colors: greenand blue.1064 nm: Removal oftattoos for all skintypes (Fitzpatrick I -VI) to treat thefollowing tattoocolors: black, brown,green, blue andpurple.The Picoway lasersystem is alsoindicated for benignpigmented lesions	The Picoplus Lasersystem is indicationfor use in surgicaland aestheticapplication in themedical specialtiesof dermatology andgeneral and plasticsurgery as follows:The 532 nmwavelength and 450pico-second pulseduration of thePICOPLUS systemis indicated for• Removal oftattoos forFitzpatrick skintypes I-III withthe followingtattoo colors:red, yellow andorange.• Treatment ofbenignpigmentedlesions removalfor FitzpatrickSkin Types I-IV.The 1064 nmwavelength and 450pico-second pulseduration of thePICOPLUS systemis indicated for:
Fitzpatrick skin	removal forFitzpatrick SkinTypes I - IV.	Removal oftattoos on allskin types(Fitzpatrick skintypes I-VI) withthe followingtattoo colors:
types I-III withthe followingtattoo colors:red, yellow andorange.	The Resolvehandpiece (1064 nm)is also indicated forthe treatment of acnescars in FitzpatrickSkin Types II - V.	black, brown,green, blue andpurple.
• Treatment ofbenignpigmentedlesions onFitzpatrick skintypes I-IV.	The Resolvehandpieces (532 nmHE, 532nm, 1064nm)are also indicated fortreatment of wrinklesin Fitzpatrick SkinTypes I - IV	• Treatment ofbenignpigmentedlesions onFitzpatrick skintypes I-IV.
	The Resolve Fusionhandpiece (1064 nm)is indicated for thetreatment of wrinklesas well as benignpigmented lesions inFitzpatrick SkinTypes I - IV	The 1064 nmwavelength andnanosecond pulseduration of thePICOPLUS systemis indicated for:
	The Resolve Fusionhandpiece (532 nm)is indicated for thetreatment of benignpigmented lesions inFitzpatrick SkinTypes I - IV.	• Treatment ofbenignpigmentedlesions onFitzpatrick skintypes I-VI
		• Removal of darkand multi-colored tattooscontaining darkcolored tattooinks onFitzpatrick skintypes I-VI
		The 532 nm

{7}------------------------------------------------

{8}------------------------------------------------

			wavelength andnanosecond pulseduration of thePICOPLUS systemis indicated for:			to be co - linear onthe laser rail so thattheir beam paths areidentical as they exitthe laser system.This allows the useof a single deliverysystem which canoutput either the 532nm or 1064nm wavelengths.	linear on the laser railso that their beampaths are identical asthey exit the lasersystem. This allowsthe use of a singledelivery systemwhich can outputeither the 532 nm or1064 nmwavelengths.
			• Treatment ofbenignpigmentedlesions onFitzpatrick skintypes I-IV	Wavelength (nm)	1064nm	532nm	1064nm	532nm	1064nm	532nm			1064 nm);Zoom handpiece(532nm, 1064 nm).
			• Removal oflighter coloredtattoo inks,including redand yellow inks,on Fitzpatrickskin types I-III	Maximumpulseenergy	500mJ	250mJ	400mJ	200mJ	800mJ(picosecond)	300mJ(picosecond)	Systemdimension	97cm H x 48cm W x97cm D	107 cm H x 46 cm Wx 69 cm D	unknown
Anatomicalsite	Skin andsubcutaneous tissue	Skin andsubcutaneous tissue		Pulseduration	300 – 500 ps		240-500ps		450ps		Systemweight	130kg	125kg	unknown
Technology	The PicoSecond Nd:YAG Laser Systemproduces a pulsedbeam of coherentnear infrared(1064nm) andvisible (532nm) light.It can crush lesionstissue efficient byinstantaneous emitlaser energy, 1064 &532nm wavelengthact on the targettissue in a short time(300-500ps). Theoutputs of the twolasers are designed	The PicoWay LaserSystem is a solid -state laser capable ofdelivering energy atwavelengths of 1064nm, 532 nm, 730 nmor 785 nm atextremely shortduration in the rangeof 240 - 500 ps.The 1064 nmwavelength can befrequency - doubledto 532 nm as desired.The outputs of thetwo lasers aredesigned to be co -	The PICOPLUSLaser System is alaser system,delivering energy atwavelengths of 1064nm and 532 nm, bothat pulse durations of450 picoseconds(ps) and 2nanoseconds (ns).The laser system iscomprised of asystem console, anarticulated arm andattachedhandpieces.	Repetitionrate	Single, 1, 2, 3, 4, 5,6, 7, 8, 9, 10 Hz		Single, 1, 2, 3, 4, 5,6, 7, 8, 9, 10 Hz		N/A		Electricalrequirements	120VAC 10A,50/60Hz	200-240 VAC, 50/60Hz, 30 A, 4600 VAsingle	unknown
Spot size	Adjustable spot size2~10mm		2, 3, 4, 5, 6, 7, 8, 9,10 mm		1064nmHandpiece 1(450ps):3, 5, 4 6mmHandpiece 2: 6, 7, 8,9, 10mm	532nmHandpiece 1(450ps): 3.3, 4.3,5.3mmHandpiece 2: 4.3,5.3, 6.5, 8mm
Beamdelivery	Articulated arm lightguide		Articulated arm lightguide		Articulated arm lightguide
Handpiece	Zoom handpiece(532nm, 1064 nm)		Resolve handpieces(532 nm HE, 532nm,1064nm);The Resolve Fusionhandpiece (532nm		Handpiece 1, 2(450ps) (1064nm,532nm)Handpiece1, 2 (2ns)(1064nm, 532nm)

{9}------------------------------------------------

{10}------------------------------------------------

The indication of the proposed device is covered by the predicate. The maximum pulse energy of the proposed device is higher than the K191683, and lower than the K113700 predicate device. It can be considered that the propose device can achieve its intended use and is safety. The handpiece types of proposed device are less than the predicate devices. This difference does not affect the safety and effective of proposed device.

VII Non-Clinical Testing

A battery of tests was performed to verify 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 60601-2-22:2007+A1: 2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements

VIII Clinical Testing

It is not applicable.

IX Conclusion

The proposed device, PicoSecond Nd: YAG Laser System has the same the

{11}------------------------------------------------

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 determined that the subject device is substantially equivalent 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.