(114 days)
PicoLO Premium 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 Premium 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 Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
PicoLO Premium 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 Premium 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.
Based on the provided text, the device in question is the PicoLO Premium, a multi-wavelength pulsed laser system intended for use in dermatology, general, and plastic surgery. The approval is based on a 510(k) submission, specifically demonstrating substantial equivalence to a predicate device, not through a clinical study that proves the device meets specific performance acceptance criteria in terms of accuracy or effectiveness in a typical AI/diagnostic device sense.
Therefore, the requested information regarding acceptance criteria and a study proving performance in the context of an AI/diagnostic device (e.g., sensitivity, specificity, MRMC study, expert ground truth) cannot be found in this document. This document focuses on demonstrating the substantial equivalence of the PicoLO Premium to a previously cleared laser system (PicoLO Nd:YAG Picosecond Laser System, K203491) based on technical characteristics and safety standards.
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests demonstrating compliance with recognized safety and performance standards for laser products, not a study evaluating diagnostic accuracy or human reader performance.
Here's a breakdown of what can be extracted and what is missing based on the prompt:
1. A table of acceptance criteria and the reported device performance:
Acceptance Criteria (Safety and Technical Performance – Not Clinical Efficacy):
The acceptance criteria are not presented in a table format with specific thresholds for clinical efficacy measures (like sensitivity or specificity). Instead, they are compliance with recognized consensus standards for laser devices. The "reported device performance" is that it was tested and found to be compliant with these standards.
| Criterion Type | Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|---|
| Laser Product Safety | 21 CFR 1040.10 and 1040.11 (relevant mandatory performance standards for laser products) | "Testing conducted on the PicoLO Premium shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11." |
| Basic Safety & Essential Performance | AAMI/ANSI ES60601-1:2005 and -A1:2012 | "All the results presented in the submission demonstrate general requirements for basic safety and essential performance." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2014 | "All the results presented here demonstrated the requirements and tests for electromagnetic disturbances." |
| Usability (Medical Devices) | IEC 60601-1-6:2010/AMD1:2013 and IEC 62366: 2008 | "All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability." and "All the results presented here demonstrated the application of usability engineering to medical devices." |
| Surgical Laser Equipment Specifics | 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." |
| Laser Product Classification & Requirements | IEC 60825-1: 2014 | "All the results presented here demonstrated the equipment classification and requirements." |
| Risk Management | ISO 14971: 2012 | "All the results presented here demonstrated the application of risk management to medical devices." |
| Biocompatibility | ISO 10993-5: 2009 and ISO 10993-10: 2010 | "Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5: 2009 and ISO 10993-10: 2010." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This type of information is not provided in the document, as it describes a 510(k) clearance based on substantial equivalence to a predicate device, relying on non-clinical performance and safety testing, not a clinical trial with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable/not provided. The "ground truth" here is compliance with engineering and safety standards, not clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. No clinical ground truth adjudication process is described.
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 information is not applicable/not provided. This is not an AI-assisted diagnostic device, but a therapeutic laser system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. This is a physical laser device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission focuses on compliance with established international and FDA-recognized consensus standards for medical device safety, electrical performance, laser specific requirements, usability, and risk management. No clinical ground truth (like pathology or outcomes data) for efficacy is required for this type of 510(k) submission, as it relies on equivalence to a predicate device.
8. The sample size for the training set:
This information is not applicable/not provided. This is a physical laser device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable/not provided. As above, no training set for a machine learning model is involved.
Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):
The "study" in this context refers to non-clinical performance and safety testing to demonstrate that the PicoLO Premium is equivalent in terms of safety and effectiveness to the predicate device, PicoLO Nd:YAG Picosecond Laser System (K203491).
- Test Set: The device itself and its components were the "test set" for various engineering and safety evaluations. The "data" are the results of these tests (e.g., electrical measurements, laser energy output, adherence to design specifications).
- Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturer's (Laseroptek Co., Ltd.) regulatory submission process. The country of origin for the device manufacturing and testing would be South Korea, where the applicant is located. The process is inherently prospective as it involves creating a new device and then testing its compliance.
- Experts/Ground Truth Establishment: The "experts" involved are likely engineers and quality assurance professionals responsible for device design, manufacturing, and testing, ensuring compliance with the specified standards. The "ground truth" is defined by the technical specifications outlined in the consensus standards themselves, against which the device's performance is measured.
- Adjudication Method: Not applicable for this type of compliance testing.
- MRMC Study/Standalone AI Performance: Not applicable as it's not an AI device.
In essence, the document confirms that the PicoLO Premium underwent a series of technical and safety evaluations to ensure it meets the established benchmarks for laser surgical instruments and is substantially equivalent to its predicate device, rather than providing data from a clinical trial demonstrating its efficacy on a patient population.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 8, 2021
Laseroptek Co., Ltd. % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul, Seoul 06210 Korea. South
Re: K212573
Trade/Device Name: PicoLO Premium 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: August 13, 2021 Received: August 16, 2021
Dear Do 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.
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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 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 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
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Indications for Use
510(k) Number (if known) K212573
Device Name PicoLO Premium
Indications for Use (Describe)
PicoLO Premium 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 Premium 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 532mm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The DIA FX 1064 handpiece (1064mm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Type of Use (Select one or both, as applicable)
| Research Use (21 CFR 201.3 Subject to Change) |
|---|
| In Vitro Diagnostic Use (21 CFR 809.3 Subject to Change) |
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: | #114, #116, #117, #203, #204 Hyundai I Valley 31Galmachi-Ro, 244beon-gil, Jungwon-GuSeongnam-Si, Gyeonggi-do, 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) ceo@btsolutions.co.kr |
| Preparation Date: | November 4, 2021 |
2. Device Name and Code
| Device Trade Name: | PicoLO Premium |
|---|---|
| Common Name: | Nd:YAG Laser System |
| 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 Premium is substantially equivalent to the following devices
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Laseroptek Co., Ltd. | PicoLO Nd:YAG PicosecondLaser System | K203491 |
Table 5.1 Predicate device
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4. Device Description
PicoLO Premium 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 Premium 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 Premium 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 Premium 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 Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
PicoLO Premium 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 Premium is substantially equivalent to the following legally marketed predicate device.
| Proposed Device | Proposed Device | |
|---|---|---|
| 510(K) Number | K203491 | |
| Product Code | GEX | GEX |
| Classification /Regulation | Class II/878.4810 | Class II/878.4810 |
| Manufacturer | Laseroptek Co.,Ltd. | Laseroptek Co.,Ltd. |
Table 5.2 Comparison table between Predicate device and Proposed device
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PicoLO Premium 510(k) Summary
| Device Name | PicoLO Nd:YAG PicosecondLaser System | PicoLO Premium | Pulse Duration(Pulse Width) | 450ps (1064nm), (Accuracy ±20%)380ps (532nm), (Accuracy ±20%) | 450ps (1064nm), (Accuracy ±20%)380ps (532nm), (Accuracy ±20%) |
|---|---|---|---|---|---|
| Clearance Date | April 7, 2021 | N/A | Pulse Energy(max) | Tattoo Mode500mJ (1064nm), (Accuracy±20%)350mJ (532nm), (Accuracy ±20%) | Tattoo Mode500mJ (1064nm), (Accuracy±20%)350mJ (532nm), (Accuracy ±20%) |
| Intended Use /Indications forUse: | PicoLO laser system is intendedfor use in surgical and aestheticapplications in the medicalspecialties of dermatology andgeneral and plastic surgery. | PicoLO Premium is intended foruse in surgical and aestheticapplications in the medicalspecialties of dermatology andgeneral and plastic surgery. | PH Mode* | PH Mode* | |
| 400mJ (1064nm), (Accuracy±20%)200mJ (532nm), (Accuracy ±20%) | 400mJ (1064nm), (Accuracy±20%)200mJ (532nm), (Accuracy ±20%) | ||||
| 1064nm | 1064nm | Peak Power(Gigawatts) | 1.1 | 1.1 | |
| The 1064nm wavelength of thePicoLO laser system is indicatedfor tattoo removal for all skin types(Fitzpatrick I-VI) to treat thefollowing tattoo colors: black,brown, green, blue and purple. | The 1064nm wavelength of thePicoLO Premium is indicated fortattoo removal for all skin types(Fitzpatrick I-VI) to treat thefollowing tattoo colors: black,brown, green, blue and purple. | Aiming Beam | Laser diode, 635nm/ <5mW | Laser diode, 635nm/ <5mW | |
| 532nm | 532nm | Repetition Rate(Hz) | Single, M3, M5, 1~10Hz(Accuracy: ± 20%) | Single, M3, M5, 1~10Hz(Accuracy: ± 20%) | |
| The 532nm wavelength of thePicoLO laser system is indicatedfor tattoo removal for Fitzpatrickskin types I-III to treat thefollowing tattoo colors: red, yellowand orange. | The 532nm wavelength of thePicoLO Premium is indicated fortattoo removal for Fitzpatrick skintypes I-III to treat the followingtattoo colors: red, yellow andorange. | Spot size (mm) | 1064 (10 mm)532 (7 mm)Collimator (20 mm)Zoom (2~7 mm) | DIA FX 1064 (10mm)DIA FX 1064 S (5mm)DIA FX 532 (7mm)S20 (20mm)Collimator (10mm)Zoom (2~7 mm) | |
| Laser Type | Q-switched Nd:YAG Laser | Q-switched Nd:YAG Laser | |||
| The PicoLO laser system is alsoindicated for benign pigmentedlesions removal for FitzpatrickSkin Types I-IV. | The PicoLO Premium is alsoindicated for benign pigmentedlesions removal for FitzpatrickSkin Types I-IV. | Activation | Via foot-switch | Via foot-switch | |
| The 1064 handpiece (1064nm) isalso indicated for the treatment ofacne scars in Fitzpatrick SkinTypes II-V. | The DIA FX 1064 handpiece(1064nm) is also indicated for thetreatment of acne scars inFitzpatrick Skin Types II-V. | Display | TFT LCD Touch screen | TFT LCD Touch screen | |
| The PicoLO laser system is alsoindicated for treatment of wrinklesin Fitzpatrick Skin Types I-IV. | PicoLO Premium is also indicatedfor treatment of wrinkles inFitzpatrick Skin Types I-IV. | Cooling System | Internal water to air heat exchanger | Internal water to air heat exchanger | |
| Wavelength | 1064/532 nm (Accuracy ±20%) | 1064/532 nm (Accuracy ±20%) | Electrical Power | 220-230VAC, 50/60Hz | 220-230VAC, 50/60Hz |
| Beam DeliverySystem | Articulated Arm with Handpiece | Articulated Arm with Handpiece | |||
| SystemDimensions(mm) | 350(W) x 1080(L) x 970(H) | 350(W) x 1080(L) x 970(H) | |||
| System Weight(kg) | 110 kg | 110 kg |
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PicoLO Premium
510(k) Summary
PH mode* is intended for 3 newly added indications, as below;
-
- benign pigmented lesions removal for Fitzpatrick Skin Types I-IV,
- the treatment of acne scars in Fitzpatrick Skin Types II-V, and 2)
-
- the treatment of wrinkles in Fitzpatrick Skin Types I-IV.
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PicoLO Premium 510(k) Summary
7. Performance Data
Non-clinical tests: Testing conducted on the PicoLO Premium 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 Premium 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: 2014. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -PicoLO Premium 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 Premium is tested and evaluated according to FDA-recognized 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.
8. Substantial Equivalence
The PicoLO Premium, subject of this submission, is modifications of the PicoLO Nd:YAG Picosecond Laser System cleared under K203491.
The modifications are:
- (1) changing the names of three handpieces, and
- (2) adding new two handpieces.
These modifications do not affect technological principles between the modified device and the predicate device.
Based upon the predicted overall performance characteristics for the PicoLO Premium, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying technological principles between PicoLO Premium and the predicate device.
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9. Conclusions
The technological characteristics of the subject device PicoLO Premium are comparable to the predicate device for comparable indications for use. Thus, subject device PicoLO Premium is concluded to be substantially equivalent to the predicate.
§ 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.