(131 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 tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
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.
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.
Based on the provided document, the device in question is a PicoLO Nd:YAG Picosecond Laser System, and the document is a 510(k) summary for its premarket notification (K203491). This type of FDA submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a full clinical trial with acceptance criteria for specific performance metrics like those for an AI/ML device.
Therefore, the document does not contain the acceptance criteria and study details typically associated with proving a device (especially an AI/ML device) meets specific performance metrics. Instead, it demonstrates performance by showing compliance with recognized standards and technical characteristics comparable to a predicate device.
Here's why the requested information cannot be fully provided from this document:
- This is not an AI/ML device: The PicoLO Nd:YAG Picosecond Laser System is a laser for surgical and aesthetic applications. It's a hardware device, not a software algorithm that performs diagnostic or prognostic tasks.
- 510(k) pathway: The 510(k) clearance pathway is about demonstrating substantial equivalence to a predicate device, not about establishing novel performance benchmarks. The performance data provided are primarily non-clinical (electrical safety, EMC, usability, risk management, biocompatibility, and laser safety standards), confirming the device's build quality and operation within established safety parameters, not its efficacy compared to a numerical performance target.
- No "acceptance criteria" in the AI/ML sense: The "acceptance criteria" for this device are its compliance with various consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, ISO 10993). There are no performance metrics like sensitivity, specificity, or AUC that would involve a test set, ground truth experts, or MRMC studies.
However, I can extract and present the
information that is available in the document, framed in the context of device safety and effectiveness as demonstrated for this type of medical device clearance:
Device Type: PicoLO Nd:YAG Picosecond Laser System (Hardware device, not AI/ML)
FDA Submission Type: 510(k) Premarket Notification (K203491)
Given that this is a 510(k) submission for a laser device (not an AI/ML product), the "acceptance criteria" and "study" are not presented in terms of AI/ML performance metrics (e.g., sensitivity, specificity, F1-score) or comparative effectiveness studies with human readers. Instead, the "acceptance criteria" are compliance with relevant safety and performance standards, and the "study" involves non-clinical testing to demonstrate this compliance and substantial equivalence to a predicate device.
Here's the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a device cleared through the 510(k) pathway primarily relate to its compliance with recognized standards and its comparable performance to the predicate device. These are qualitative rather than quantitative performance metrics for a diagnostic algorithm.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| Laser Product Safety: 21 CFR 1040.10 and 1040.11 | Tested and evaluated according to these mandatory standards. |
| Basic Safety & Essential Performance: AAMI/ANSI ES60601-1:2005 and A1:2012 | All results demonstrate general requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2: 2007 | All results demonstrated the requirements and tests for electromagnetic disturbances. |
| Usability (General Requirements): IEC 60601-1-6:2010/AMD1:2013 | All results demonstrated the General requirements for safety - Collateral Standard: Usability. |
| Usability (Engineering): IEC 62366: 2008 | Usability was documented according to this standard. |
| Surgical Laser Equipment Safety: IEC 60601-2-22: 2007 (Third Edition) + A1:2012 | All results 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 results demonstrated the equipment classification and requirements. |
| Risk Management: ISO 14971: 2012 | Risk management was recorded according to this standard. |
| Biocompatibility: ISO 10993-5: 2009 and ISO 10993-10: 2010 | Tested and evaluated according to these standards. |
| Substantial Equivalence: To predicate device (K183392) for existing indications and to reference device (K170597) for new indications. | The technological characteristics and expanded intended use are considered substantially equivalent, with no significant differences in underlying technological principles. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable in the context of an AI/ML algorithm's performance study. The "testing" here refers to engineering and safety validation, not a clinical test set of patient data.
- Data provenance: Not applicable. The "data" are measurements from non-clinical laboratory tests and engineering evaluations of the device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This device is a laser system, not an AI assistance tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" equivalent for this device's clearance pertains to compliance with engineering standards and safety requirements.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
- Not applicable.
Summary regarding this specific document:
This document is a 510(k) summary for a laser medical device. It demonstrates safety and effectiveness through compliance with recognized consensus standards and by showing substantial equivalence to a previously cleared predicate device and a reference device for new indications. It does not provide information relevant to the types of studies and acceptance criteria typically associated with AI/ML-based medical devices or comparative effectiveness studies involving human readers and AI assistance.
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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.
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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 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
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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.
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.
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)
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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: | 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 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
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Laseroptek Co., Ltd. | PicoLO Nd:YAG PicosecondLaser System | K183392 |
Table 5.1 Predicate device
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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.
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.
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 LIVEPredicate Device | Proposed Device | |||
|---|---|---|---|---|
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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 forUse: | 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.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. | 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.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.The PicoLO laser system is also indicatedfor benign pigmented lesions removal forFitzpatrick Skin Types I-IV.The 1064 handpiece (1064nm) is alsoindicated for the treatment of acne scars inFitzpatrick Skin Types II-V.The PicoLO laser system is also indicatedfor treatment of wrinkles in Fitzpatrick SkinTypes 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 Mode500mJ (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 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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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
-
- 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 forUse: | The PicoWay laser system is indicated forthe following at the specified wavelength: | PicoLO laser system is intended for use insurgical and aesthetic applications in the |
| 532nm: Removal of tattoos for Fitzpatrickskin types I-III to treat the following tattoocolors: red, yellow and orange. | medical specialties of dermatology andgeneral and plastic surgery. | |
| 785nm: Removal of tattoos for Fitzpatrickskin types II-IV to treat the following tattoocolors: green and blue.1064nm: Removal of tattoos for all skintypes (Fitzpatrick I-VI) to treat thefollowing tattoo colors: black, brown, | ||
| 1064nm | ||
| The 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. | ||
| green, blue and purple. | 532nm | |
| The PicoWay laser system is also indicatedfor benign pigmented lesions removal forFitzpatrick Skin Types I-IV. | The 532nm wavelength of the PicoLO lasersystem is indicated for tattoo removal forFitzpatrick skin types I-III to treat thefollowing tattoo colors: red, yellow and | |
| The Resolve handpiece (1064 nm) is alsoindicated for the treatment of acne scars inFitzpatrick Skin Types II-V. | orange. | |
| The Resolve handpieces are also indicated | ||
| for treatment of wrinkles in Fitzpatrick SkinTypes I-IV. | The PicoLO laser system is also indicatedfor benign pigmented lesions removal forFitzpatrick Skin Types I-IV. | |
| The 1064 handpiece (1064nm) is alsoindicated for the treatment of acne scars inFitzpatrick Skin Types II-V. | ||
| The PicoLO laser system is also indicatedfor treatment of wrinkles in Fitzpatrick SkinTypes I-IV. | ||
| 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 (6x6mm²)Fractional and non-fractional 532 (6x6mm²) | 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 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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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.
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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.
§ 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.