(28 days)
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 Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
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 Q-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.
This document describes the PicoLO Nd:YAG Picosecond Laser System, a device intended for surgical and aesthetic applications in dermatology and general and plastic surgery, specifically for tattoo removal.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the device's performance in terms of clinical outcomes (e.g., percentage of tattoo clearance). Instead, it focuses on demonstrating substantial equivalence to a predicate device (PicoWay Laser System) through technical performance data and adherence to regulatory standards.
Therefore, the "acceptance criteria" are implied by the equivalency claims and adherence to safety and performance standards. The reported device performance is presented as compliance with these standards and technical specifications comparable to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|
| Safety & Essential Performance | Tested and evaluated according to AAMI/ANSI ES60601-1:2005 and A1:2012. All results demonstrate general requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC) | Tested and evaluated per FDA-recognized consensus standard IEC 60601-1-2:2007. All results demonstrate requirements and tests for electromagnetic disturbances. |
| Usability | Tested and evaluated per FDA-recognized consensus standard IEC 60601-1-6:2010/AMD1:2013 and documented according to IEC 62366:2008. All results demonstrate usability requirements. |
| Particular Requirements for Surgical Lasers | Tested and evaluated per FDA-recognized consensus standard IEC 60601-2-22:2007 (Third Edition) + A1:2012. All results demonstrate particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. |
| Laser Product Safety Classification & Requirements | Evaluated per IEC 60825-1:2014. All results demonstrate equipment classification and requirements. |
| Risk Management | Recorded according to FDA-recognized consensus standard ISO 14971:2012. All results demonstrate the application of risk management to medical devices. |
| Biocompatibility | Tested and evaluated per FDA-recognized consensus standard ISO 10993-5:2009 and ISO 10993-10:2010. |
| Technical Characteristics (vs. Predicate K170597 PicoWay Laser System) | Wavelengths: 1064nm, 532nm (The proposed device produces these two wavelengths, which are within the scope of the predicate's 532nm, 1064nm, and 785nm wavelengths). Pulse Duration: 450ps (1064nm), 380ps (532nm) (Accuracy ±20%) - Similar to predicate's 450ps (1064nm), 375ps (532nm). Pulse Energy (max): 500mJ (1064nm), 350mJ (532nm) (Accuracy ±20%) - Comparable to predicate's 400mJ (1064nm), 200mJ (532nm). Peak Power (Gigawatts): 1.1 - Comparable to predicate's Up to 0.9. Repetition Rate: Single, M3, M5, 1-10Hz (Accuracy: ±20%) - Similar to predicate's Single, 1-10 Hz. Laser Type: Q-switched Nd:YAG Laser - Matches predicate. |
2. Sample size used for the test set and the data provenance:
The document focuses on non-clinical (engineering and regulatory standard) testing and explicitly states: "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..."
- Sample Size: The document does not specify a "sample size" in the context of human subjects or clinical data for performance testing. The "tests" described are related to the device itself and its compliance with engineering and safety standards (e.g., electrical safety, EMC, laser safety).
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based evaluations of the device's physical and electronic characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the submission relies on demonstrating substantial equivalence through technical testing and adherence to recognized consensus standards, rather than a clinical study requiring expert-established ground truth for a test set. The "ground truth" for the non-clinical tests is defined by the requirements of the standards themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable to the non-clinical testing performed. Adjudication methods are typically used in clinical studies where human interpretation or assessment of an outcome is required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a laser system for tattoo removal, not an AI-assisted diagnostic or interpretative tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical laser system, not an algorithm, and its use inherently involves a human operator (a medical professional).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance data presented, the "ground truth" is established by adherence to and measurement against the requirements and specifications detailed in the cited FDA-recognized consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, ISO 10993).
8. The sample size for the training set:
This is not applicable. There is no mention of a "training set" as the submission is for a physical laser device and its substantial equivalence, not a machine learning or AI-based product.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
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January 4, 2019
Laseroptek Co., Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K183392
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: December 6, 2018 Received: December 7, 2018
Dear Mark Job:
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/ofdocs/ofpmn.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 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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183392
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.
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 Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | #116, #117, #203, #204 Hyundai I Valley 31Galmachi-Ro, 244beon-gil, Jungwon-GuSeongnam-Si, Gyeonggido, 13212Rep. of Korea (South Korea)Tel) +82.31.8023.5150Fax) +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 KoreaTel) +82.2.538.9140Email) smanager@btsolutions.co.kr |
| Preparation Date: | January-3-2019 |
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 plasticsurgery 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
| 1 0010 J.1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1Applicant | Device Name | 510(k) Number |
|---|---|---|
| Syneron Candela | PicoWay Laser System | K170597 |
| Corporation |
Table 5.1 Predicate device
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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 Q-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.
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.
6. Technical Characteristics in Comparison to Predicate Devices
PicoLO Nd:YAG Picosecond Laser System is substantially equivalent to the following legally marketed predicate device.
| Predicate Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K170597 | N/A |
| 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 forUse: | The PicoWay laser system is indicated forthe following at the specified wavelength:532nm: Removal of tattoos for Fitzpatrickskin types I-III to treat the following tattoocolors: red, yellow and orange.785nm: Removal of tattoos for Fitzpatrickskin types II-IV to treat the following tattoocolors: green and blue. | PicoLO laser system is intended for use insurgical and aesthetic applications in themedical specialties of dermatology andgeneral and plastic surgery.1064nmThe 1064nm wavelength of the PicoLOlaser system is indicated for tattoo removalfor all skin types (Fitzpatrick I-VI) to treatthe following tattoo colors: black, brown,green, blue and purple. |
| 1064nm: Removal of tattoos for all skintypes (Fitzpatrick I-VI) to treat thefollowing tattoo colors: black, brown,green, blue and purple.The PicoWay laser system is also indicatedfor benign pigmented lesions removal forFitzpatrick Skin Types I-IV.The Resolve handpiece (1064 nm) is alsoindicated for the treatment of acne scars inFitzpatrick Skin Types II-V.The Resolve handpieces are also indicatedfor treatment of wrinkles in Fitzpatrick SkinTypes I-IV. | 532nmThe 532nm wavelength of the PicoLO lasersystem is indicated for tattoo removal forFitzpatrick skin types I-III to treat thefollowing tattoo colors: red, yellow andorange. | |
| Wavelength | 532nm, 1064nm785 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 VAsingle | 220-230VAC, 50/60Hz |
| Beam DeliverySystem | Articulated Arm with Handpiece | Articulated Arm with Handpiece |
| SystemDimensions(mm) | 1070 (H) x 460 (W) x 690 (D) | 350(W) x 1080(L) x 970(H) |
| System Weight(kg) | 125 kg | 110 kg |
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510(k) Summary
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6. 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 FDA-recognized 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.
7. Substantial Equivalence
PicoLO Nd:YAG Picosecond Laser System and the predicate device are both intended for prescription use. The intended use of PicoLO Nd:YAG Picosecond Laser System is within the scope of the predicate device. The predicate device produces 3 wavelengths which are 1064 mm, 532 nm and 785 nm, while the proposed device produces dual wavelength which are 1064 nm and 532 mm. The wavelengths of the proposed device's wavelengths are within the scope of the predicate device. When compare at the same wavelength, the laser parameter of the proposed device is very similar.
Based upon the predicted overall performance characteristics for the PicoLO Nd: Y AG Picosecond Laser System, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying technological principles between PicoLO Nd:YAG Picosecond Laser System and the predicate device.
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8. Conclusions
The technological characteristics of the subject device PicoLO Nd: Y AG Picosecond Laser System are comparable to those of the predicates for comparable indications for use. Thus, subject device PicoLO is concluded to be substantially equivalent to the predicates.
§ 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.