Who is the manufacturer of PicoLO Nd: YAG Picosecond Laser System?

Laseroptek Co., Ltd. filed the 510(k) submission for PicoLO Nd: YAG Picosecond Laser System (K203491).

What is the FDA product code for PicoLO Nd: YAG Picosecond Laser System?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for PicoLO Nd: YAG Picosecond Laser System?

510(k) clearance (submission type: Special).

What are the predicate devices for PicoLO Nd: YAG Picosecond Laser System?

PicoLO Nd:YAG Picosecond Laser System (K183392).

Who can help prepare an FDA 510(k) submission like PicoLO Nd: YAG Picosecond Laser System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PicoLO Nd: YAG Picosecond Laser System

K203491 · Laseroptek Co., Ltd. · GEX · Apr 7, 2021 · General, Plastic Surgery

Device Facts

Record ID	K203491
Device Name	PicoLO Nd: YAG Picosecond Laser System
Applicant	Laseroptek Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Apr 7, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. <Tattoo Mode> 1064nm The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. 532nm The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. <PH Mode> The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Device Story

Multi-wavelength, pulsed Q-switched Nd:YAG picosecond laser system; delivers thermal energy to epidermis and dermis via focusing optics; used in dermatology, general, and plastic surgery; operated by clinicians. System comprises main body, color touch screen, articulated arm, handpiece, and foot switch. Input: user-selected parameters via interface; Output: laser pulses at 1064nm or 532nm. Device facilitates removal of tattoos, pigmented lesions, acne scars, and wrinkles. Clinical benefit derived from targeted thermal energy delivery to skin tissue.

Clinical Evidence

Bench testing only. Performance evaluated against standards: AAMI/ANSI ES60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 60601-2-22 (laser safety), IEC 60825-1 (laser classification), ISO 14971 (risk management), and ISO 10993-5/10 (biocompatibility). No clinical data presented.

Technological Characteristics

Q-switched Nd:YAG laser; wavelengths 1064nm/532nm; pulse durations 450ps (1064nm)/380ps (532nm); max energy 500mJ/350mJ (Tattoo mode), 400mJ/200mJ (PH mode); articulated arm delivery; internal water-to-air heat exchanger; 220-230VAC power; TFT LCD touch interface; foot-switch activation.

Indications for Use

Indicated for tattoo removal (1064nm: Fitzpatrick I-VI, black/brown/green/blue/purple; 532nm: Fitzpatrick I-III, red/yellow/orange), benign pigmented lesions removal (Fitzpatrick I-IV), acne scar treatment (1064nm, Fitzpatrick II-V), and wrinkle treatment (Fitzpatrick 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

PicoLO Nd:YAG Picosecond Laser System (K183392)

Reference Devices

PicoWay Laser System (K170597)

Related Devices

K220268 — Picosecond Laser System (Model PS10-A and PS10-B) · Beijing Adss Development Co., Ltd. · Aug 23, 2022
K183392 — PicoLO Nd:YAG Picosecond Laser System · Laseroptek Co., Ltd. · Jan 4, 2019
K212573 — PicoLO Premium · Laseroptek Co., Ltd. · Dec 8, 2021
K182997 — enlighten III Laser System · Cutera, Inc. · Dec 12, 2018
K190936 — Q-Switched Nd: YAG Laser System · Shanghai Apolo Medical Technology Co., Ltd. · Jun 17, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 USA 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. April 7, 2021 Laseroptek Co., Ltd. % Do Hyun Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South Re: K203491 Trade/Device Name: PicoLO Nd: YAG Picosecond 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: November 23, 2020 Received: November 27, 2020 Dear Do Hyun Kim: 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 mediation-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, # Purva U. Pandya -S Purva Pandya 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}------------------------------------------------ #### Indications for Use #### 510(k) Number (if known) K203491 Device Name PicoLO Nd:YAG Picosecond Laser System #### Indications for Use (Describe) PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. #### <Tattoo Mode> 1064nm The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. #### 532nm The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. <PH Mode> The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-------------------------------------------| | | For Testing Under 21 CFR 58 Subpart D | | | For The Control Under 21 CFR 58 Subpart G | X 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 5. 510(k) Summary ## 1. General Information | Applicant/Submitter: | Laseroptek Co., Ltd. | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | #114, #116, #117, #203, #204 Hyundai I Valley 31 Galmachi-Ro, 244beon-gil, Jungwon-Gu Seongnam-Si, Gyeonggi-do, 13212 Rep. of Korea (South Korea) Tel) +82.31.8023.5150 Fax) +82.31.8023.5151 | | Contact Person: | Do-Hyun Kim, BT Solutions, Inc. | | Address: | 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210, Republic of Korea Tel) +82.2.538.9140 Email) ceo@btsolutions.co.kr | | Preparation Date: | March 5, 2021 | ## 2. Device Name and Code | Device Trade Name: | PicoLO Nd:YAG Picosecond Laser System | |----------------------|----------------------------------------------------------------------------------------| | Common Name: | Nd:YAG Laser | | Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Product Code: | GEX | | Regulation Number: | 878.4810 | | Classification: | Class II | | Review Panel: | General & Plastic Surgery (ODE) | ## 3. Predicate Device PicoLO Nd: YAG Picosecond Laser System is substantially equivalent to the following devices | Applicant | Device Name | 510(k) Number | |----------------------|------------------------------------------|---------------| | Laseroptek Co., Ltd. | PicoLO Nd:YAG Picosecond Laser System | K183392 | #### Table 5.1 Predicate device {4}------------------------------------------------ Reference Device: Syneron Candela Corporation's PicoWay Laser System (K170597) #### 4. Device Description The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of O-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch. #### 5. Indications / Intended Use PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. <Tattoo Mode> 1064nm The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. 532nm The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. <PH Mode> The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. ## 6. Technical Characteristics in Comparison ## 6.1. Technical Characteristics in Comparison to Predicate Device PicoLO Nd: YAG Picosecond Laser System is substantially equivalent to the following legally marketed predicate device. Table 5 2 Comparison table hetween Predicate device and Proposed device | | TWOTE OULLYWOOD WOLF OVER POLL LAWINGS OF LAS WIN LIVE OF LOG AND LIVE Predicate Device | Proposed Device | | | |--|--------------------------------------------------------------------------------------------|-----------------|--|--| | | | | | | {5}------------------------------------------------ ## PicoLO Nd:YAG Picosecond Laser System 510(k) Summary | 510(K) Number | K183392 | K203491 | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | GEX | GEX | | Classification / Regulation | Class II/878.4810 | Class II/878.4810 | | Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. | | Device Name | PicoLO Nd:YAG Picosecond Laser System | PicoLO Nd:YAG Picosecond Laser System | | Clearance Date | 11 Feb 2019 | N/A | | Intended Use / Indications for Use: | PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064nm The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. 532nm The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. | PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. <Tattoo Mode> 1064nm The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. 532nm The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. <PH Mode> The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. | | Wavelength | 1064/532 nm (Accuracy ±20%) | 1064/532 nm (Accuracy ±20%) | | Pulse Duration (Pulse Width) | 450ps (1064nm), (Accuracy ±20%) 380ps (532nm), (Accuracy ±20%) | 450ps (1064nm), (Accuracy ±20%) 380ps (532nm), (Accuracy ±20%) | | Pulse Energy (max) | 500mJ (1064nm), (Accuracy ±20%) 350mJ (532nm), (Accuracy ±20%) | Tattoo Mode 500mJ (1064nm), (Accuracy ±20%) 350mJ (532nm), (Accuracy ±20%) PH Mode* 400mJ (1064nm), (Accuracy ±20%) | | | | 200mJ (532nm), (Accuracy ±20%) | | Peak Power (Gigawatts) | 1.1 | 1.1 | | Aiming Beam | Laser diode, 635nm/ <5mW | Laser diode, 635nm/ <5mW | | Repetition Rate (Hz) | Single, M3, M5, 1~10Hz (Accuracy: ± 20%) | Single, M3, M5, 1~10Hz (Accuracy: ± 20%) | | Spot size (mm) | 1064 (10 mm) 532 (7 mm) Collimator (20 mm) Zoom (2~7 mm) | 1064 (10 mm) 532 (7 mm) Collimator (20 mm) Zoom (2~7 mm) | | Laser Type | Q-switched Nd:YAG Laser | Q-switched Nd:YAG Laser | | Activation | Via foot-switch | Via foot-switch | | Display | TFT LCD Touch screen | TFT LCD Touch screen | | Cooling System | Internal water to air heat exchanger | Internal water to air heat exchanger | | Electrical Power | 220-230VAC, 50/60Hz | 220-230VAC, 50/60Hz | | Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | | System Dimensions(mm) | 350(W) x 1080(L) x 970(H) | 350(W) x 1080(L) x 970(H) | | System Weight (kg) | 110 kg | 110 kg | {6}------------------------------------------------ PH mode* is intended for 3 newly added indications, as below; - 1) benign pigmented lesions removal for Fitzpatrick Skin Types I-IV, - 2) the treatment of acne scars in Fitzpatrick Skin Types II-V, and - 3) the treatment of wrinkles in Fitzpatrick Skin Types I-IV. #### 6.2. Technical Characteristics in Comparison to Reference Device Table 5.3 Comparison table between Reference device and Proposed device | | Reference Device | Proposed Device | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) Number | K170597 | K203491 | | Product Code | GEX | GEX | | Classification / Regulation | Class II/878.4810 | Class II/878.4810 | | Manufacturer | Syneron Candela Corporation | Laseroptek Co.,Ltd. | | Device Name | PicoWay Laser System | PicoLO Nd:YAG Picosecond Laser System | | Clearance Date | 25 May 2017 | N/A | | Intended Use / Indications for Use: | The PicoWay laser system is indicated for the following at the specified wavelength: | PicoLO laser system is intended for use in surgical and aesthetic applications in the | | | 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. | medical specialties of dermatology and general and plastic surgery. | | | 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, | <Tattoo Mode> | | | | 1064nm | | | | The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. | | | green, blue and purple. | 532nm | | | The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. | The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and | | | The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. | orange. | | | The Resolve handpieces are also indicated | <PH Mode> | | | for treatment of wrinkles in Fitzpatrick Skin Types I-IV. | The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. | | | | The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. | | | | The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. | | Wavelength | 532nm, 1064nm 785 nm | 1064/532 nm (Accuracy ±20%) | | Pulse Duration (Pulse Width) | 450ps (1064nm) 375ps (532nm) | 450ps (1064nm), (Accuracy ±20%) 380ps (532nm), (Accuracy ±20%) | | Pulse Energy (max) | 400mJ (1064nm) 200mJ (532nm) | 500mJ (1064nm), (Accuracy ±20%) 350mJ (532nm), (Accuracy ±20%) | | Peak Power (Gigawatts) | Up to 0.9 | 1.1 | | Aiming Beam | Unknown | Laser diode, 635nm/ <5mW | | Repetition Rate (Hz) | Single, 1-10 Hz (1064nm and 532 nm) | Single, M3, M5, 1~10Hz (Accuracy: ± 20%) | | Spot size (mm) | Zoom 2-10 mm (1064nm and 532nm) Fractional and non-fractional 1064 (6x6 mm²) Fractional and non-fractional 532 (6x6 mm²) | 1064 (10 mm) 532 (7 mm) Collimator (20 mm) Zoom (2~7 mm) | | Laser Type | Q-switched Nd:YAG Laser | Q-switched Nd:YAG Laser | | Activation | Via foot-switch | Via foot-switch | | Display | LCD Touch screen | TFT LCD Touch screen | | Cooling System | Unknown | Internal water to air heat exchanger | | Electrical Power | 200-240 VAC, 50/60 Hz, 30 A, 4600 VA single | 220-230VAC, 50/60Hz | | Beam Delivery System | Articulated Arm with Handpiece | Articulated Arm with Handpiece | | System Dimensions(mm) | 1070 (H) x 460 (W) x 690 (D) | 350(W) x 1080(L) x 970(H) | | System Weight (kg) | 125 kg | 110 kg | {7}------------------------------------------------ ## 510(k) Summary {8}------------------------------------------------ #### 7. Performance Data Non-clinical tests: Testing conducted on the PicoLO Nd:YAG Picosecond Laser System shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following standards: - PicoLO Nd:YAG Picosecond Laser System is tested and evaluated according to -AAMI/ANSI ES60601-1:2005 and A1:2012. All the results presented in the submission demonstrate general requirements for basic safety and essential performance. - -Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances. - -PicoLO Nd:YAG Picosecond Laser System is tested and evaluated according to FDArecognized consensus standard IEC 60601-1-6:2010/AMD1:2013. All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability. - -PicoLO Nd:YAG Picosecond Laser System is tested and evaluated according to FDArecognized consensus standard IEC 60601-2-22: 2007 (Third Edition) + A1:2012. All the results presented here demonstrated the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. - -Safety of laser products is evaluated according IEC 60825-1: 2014. All the results presented here demonstrated the equipment classification and requirements. - Risk management was recorded according to the FDA-recognized consensus standard ISO -14971: 2012. All the results presented here demonstrated the application of risk management to medical devices. - -Usability was documented according to the FDA-recognized consensus standard IEC 62366: 2008. All the results presented here demonstrated the application of usability engineering to medical devices. - Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5: 2009 and ISO 10993-10: 2010. {9}------------------------------------------------ #### 8. Substantial Equivalence The modified PicoLO Nd:YAG Picosecond Laser System, subject of this submission, is a modification of the PicoLO Nd:YAG Picosecond Laser System cleared under K183392. The intended use of the modified device is expanded as compared with the predicate device. This expansion does not affect technological principles between the modified device and the predicate device. Based upon the predicted overall performance characteristics for the PicoLO Nd: Y AG Picosecond Laser System, Laseroptek Co. Ltd. believes that no sigmificant differences exist in usage of its underlying technological principles between PicoLO Nd:YAG Picosecond Laser System and the predicate device. #### 9. Conclusions The technological characteristics of the subject device PicoLO Nd: Y AG Picosecond Laser System are comparable to the predicate device for comparable indications for use. Thus, subject device PicoLO is concluded to be substantially equivalent to the predicates.