PicoSecond Nd: YAG Laser System
Device Facts
| Record ID | K200116 |
|---|---|
| Device Name | PicoSecond Nd: YAG Laser System |
| Applicant | Shanghai Apolo Medical Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 28, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications 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.
Device Story
PicoSecond Nd:YAG Laser System is a solid-state laser delivering picosecond pulse bursts (300-500ps) to skin. System components include laser generator, articulated arm, handpiece, power supply, cooling system, and display/control system. Device produces co-linear 1064nm (near-infrared) and 532nm (visible) pulsed light beams directed via articulated arm to treatment zone. Used in clinical dermatology, general, and plastic surgery settings by trained professionals. Output energy targets tissue to crush lesions or break down tattoo ink particles. Clinical benefit includes removal of tattoos and treatment of benign pigmented lesions. Device operation involves selecting wavelength and parameters via control system; provider monitors treatment area during application.
Clinical Evidence
No clinical data. Substantial equivalence established via bench testing and comparison of technological characteristics.
Technological Characteristics
Solid-state Nd:YAG laser; wavelengths 1064nm/532nm; pulse duration 300-500ps; repetition rate 1-10Hz; adjustable spot size 2-10mm; articulated arm beam delivery. Electrical safety/EMC compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
Indications for Use
Indicated for tattoo removal and benign pigmented lesion treatment in dermatology, general, and plastic surgery. 1064nm: tattoo removal (all skin types I-VI; black, brown, green, blue, purple ink) and benign pigmented lesions (types I-IV). 532nm: tattoo removal (types I-III; red, yellow, orange ink) and benign pigmented lesions (types I-IV).
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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.
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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
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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.
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.
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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
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# 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 |
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#### Lutronic Corporation Manufacturer
# 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.
### 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:<br>YAG Laser System | PicoWay Laser System | Picoplus laser system |
| Product Code | GEX | GEX | GEX |
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| Regulation<br>No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class | Class II | Class II | Class II |
| Indication<br>for use | The PicoSecond Nd:<br>YAG Laser System<br>is intended for use in<br>surgical and<br>aesthetic application<br>in the medical<br>dermatology and<br>general and plastic<br>surgery as follows:<br>1064nm<br>wavelength:<br>• Removal of<br>tattoos on all<br>skin type<br>(Fitzpatrick skin<br>types I-VI) with<br>the following<br>tattoo colors:<br>black, brown,<br>green, blue and<br>purple.<br>• Treatment of<br>benign<br>pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-IV.<br>532nm wavelength:<br>• Removal of | The PicoWay laser<br>system is indicated<br>for the following at<br>the specified<br>wavelength<br>532 nm: Removal of<br>tattoos for Fitzpatrick<br>skin types I - III to<br>treat the following<br>tattoo colors: red,<br>yellow and orange.<br>730 nm: Removal of<br>tattoos for Fitzpatrick<br>skin types II - IV to<br>treat the following<br>tattoo colors: green<br>and blue.<br>785 nm: Removal of<br>tattoos for Fitzpatrick<br>skin types II - IV to<br>treat the following<br>tattoo colors: green<br>and blue.<br>1064 nm: Removal of<br>tattoos for all skin<br>types (Fitzpatrick I -<br>VI) to treat the<br>following tattoo<br>colors: black, brown,<br>green, blue and<br>purple.<br>The Picoway laser<br>system is also<br>indicated for benign<br>pigmented lesions | The Picoplus Laser<br>system is indication<br>for use in surgical<br>and aesthetic<br>application in the<br>medical specialties<br>of dermatology and<br>general and plastic<br>surgery as follows:<br>The 532 nm<br>wavelength and 450<br>pico-second pulse<br>duration of the<br>PICOPLUS system<br>is indicated for<br>• Removal of<br>tattoos for<br>Fitzpatrick skin<br>types I-III with<br>the following<br>tattoo colors:<br>red, yellow and<br>orange.<br>• Treatment of<br>benign<br>pigmented<br>lesions removal<br>for Fitzpatrick<br>Skin Types I-IV.<br>The 1064 nm<br>wavelength and 450<br>pico-second pulse<br>duration of the<br>PICOPLUS system<br>is indicated for: |
| Fitzpatrick skin | removal for<br>Fitzpatrick Skin<br>Types I - IV. | Removal of<br>tattoos on all<br>skin types<br>(Fitzpatrick skin<br>types I-VI) with<br>the following<br>tattoo colors: | |
| types I-III with<br>the following<br>tattoo colors:<br>red, yellow and<br>orange. | The Resolve<br>handpiece (1064 nm)<br>is also indicated for<br>the treatment of acne<br>scars in Fitzpatrick<br>Skin Types II - V. | black, brown,<br>green, blue and<br>purple. | |
| • Treatment of<br>benign<br>pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-IV. | The Resolve<br>handpieces (532 nm<br>HE, 532nm, 1064nm)<br>are also indicated for<br>treatment of wrinkles<br>in Fitzpatrick Skin<br>Types I - IV | • Treatment of<br>benign<br>pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-IV. | |
| | The Resolve Fusion<br>handpiece (1064 nm)<br>is indicated for the<br>treatment of wrinkles<br>as well as benign<br>pigmented lesions in<br>Fitzpatrick Skin<br>Types I - IV | The 1064 nm<br>wavelength and<br>nanosecond pulse<br>duration of the<br>PICOPLUS system<br>is indicated for: | |
| | The Resolve Fusion<br>handpiece (532 nm)<br>is indicated for the<br>treatment of benign<br>pigmented lesions in<br>Fitzpatrick Skin<br>Types I - IV. | • Treatment of<br>benign<br>pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-VI | |
| | | • Removal of dark<br>and mult<br>i-colored tattoos<br>containing dark<br>colored tattoo<br>inks on<br>Fitzpatrick skin<br>types I-VI | |
| | | The 532 nm | |
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| | | | wavelength and<br>nanosecond pulse<br>duration of the<br>PICOPLUS system<br>is indicated for: | | | to be co - linear on<br>the laser rail so that<br>their beam paths are<br>identical as they exit<br>the laser system.<br>This allows the use<br>of a single delivery<br>system which can<br>output either the 532<br>nm or 1064<br>nm wavelengths. | linear on the laser rail<br>so that their beam<br>paths are identical as<br>they exit the laser<br>system. This allows<br>the use of a single<br>delivery system<br>which can output<br>either the 532 nm or<br>1064 nm<br>wavelengths. | | | | | | | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|---------------------------|---------------------------|----------------------------|-----------------------------|---------------------------------------------------|---------|
| | | | • Treatment of<br>benign<br>pigmented<br>lesions on<br>Fitzpatrick skin<br>types I-IV | Wavelengt<br>h (nm) | 1064nm | 532nm | 1064nm | 532nm | 1064nm | 532nm | | | 1064 nm);<br>Zoom handpiece<br>(532nm, 1064 nm). | |
| | | | • Removal of<br>lighter colored<br>tattoo inks,<br>including red<br>and yellow inks,<br>on Fitzpatrick<br>skin types I-III | Maximum<br>pulse<br>energy | 500mJ | 250mJ | 400mJ | 200mJ | 800mJ<br>(picosec<br>ond) | 300mJ<br>(picosec<br>ond) | System<br>dimension | 97cm H x 48cm W x<br>97cm D | 107 cm H x 46 cm W<br>x 69 cm D | unknown |
| Anatomical<br>site | Skin and<br>subcutaneous tissue | Skin and<br>subcutaneous tissue | | Pulse<br>duration | 300 – 500 ps | | 240-500ps | | 450ps | | System<br>weight | 130kg | 125kg | unknown |
| Technology | The PicoSecond Nd:<br>YAG Laser System<br>produces a pulsed<br>beam of coherent<br>near infrared<br>(1064nm) and<br>visible (532nm) light.<br>It can crush lesions<br>tissue efficient by<br>instantaneous emit<br>laser energy, 1064 &<br>532nm wavelength<br>act on the target<br>tissue in a short time<br>(300-500ps). The<br>outputs of the two<br>lasers are designed | The PicoWay Laser<br>System is a solid -<br>state laser capable of<br>delivering energy at<br>wavelengths of 1064<br>nm, 532 nm, 730 nm<br>or 785 nm at<br>extremely short<br>duration in the range<br>of 240 - 500 ps.<br>The 1064 nm<br>wavelength can be<br>frequency - doubled<br>to 532 nm as desired.<br>The outputs of the<br>two lasers are<br>designed to be co - | The PICOPLUS<br>Laser System is a<br>laser system,<br>delivering energy at<br>wavelengths of 1064<br>nm and 532 nm, both<br>at pulse durations of<br>450 picoseconds<br>(ps) and 2<br>nanoseconds (ns).<br>The laser system is<br>comprised of a<br>system console, an<br>articulated arm and<br>attached<br>handpieces. | Repetition<br>rate | Single, 1, 2, 3, 4, 5,<br>6, 7, 8, 9, 10 Hz | | Single, 1, 2, 3, 4, 5,<br>6, 7, 8, 9, 10 Hz | | N/A | | Electrical<br>requirements | 120VAC 10A,<br>50/60Hz | 200-240 VAC, 50/60<br>Hz, 30 A, 4600 VA<br>single | unknown |
| Spot size | Adjustable spot size<br>2~10mm | | 2, 3, 4, 5, 6, 7, 8, 9,<br>10 mm | | 1064nm<br>Handpiece 1<br>(450ps):<br>3, 5, 4 6mm<br>Handpiece 2: 6, 7, 8,<br>9, 10mm | 532nm<br>Handpiece 1<br>(450ps): 3.3, 4.3,<br>5.3mm<br>Handpiece 2: 4.3,<br>5.3, 6.5, 8mm | | | | | | | | |
| Beam<br>delivery | Articulated arm light<br>guide | | Articulated arm light<br>guide | | Articulated arm light<br>guide | | | | | | | | | |
| Handpiece | Zoom handpiece<br>(532nm, 1064 nm) | | Resolve handpieces<br>(532 nm HE, 532nm,<br>1064nm);<br>The Resolve Fusion<br>handpiece (532nm | | Handpiece 1, 2<br>(450ps) (1064nm,<br>532nm)<br>Handpiece1, 2 (2ns)<br>(1064nm, 532nm) | | | | | | | | | |
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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
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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.
