(211 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or data training/testing for algorithmic performance. The device description focuses on the laser technology and delivery system.
Yes
The device is used for UVB phototherapy of various skin conditions like psoriasis and vitiligo, which are therapeutic interventions.
No
The device description states its intended use is for "UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin," which describes treatment, not diagnosis. It is a "laser light source and optical energy delivery system" for targeted therapy.
No
The device description clearly outlines a physical laser system with a console, handpiece, and articulating arm, indicating it is a hardware device that utilizes software for control and user interface. The performance studies also focus on hardware-related standards and measurements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin." This describes a therapeutic treatment applied directly to the patient's skin.
- Device Description: The device is a "Solid-State UV laser system" that provides "targeted energy to the treatment site." This is a physical therapy device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of any biological specimens.
The information provided clearly indicates this is a medical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indication for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
affected skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: Measurement of wavelength, average output power, and energy fluence (in units of mW/cm2) of treatment were performed. Testing conducted on the PALLAS 308/311 Solid-State UV 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 consensus standards:
- PALLAS 308/311 Solid-State UV Laser System is tested and evaluated according to IEC 60601-1:2005 (Third Edition) + CORR.1:2006+ CORR. 2:2007 + A1:2012 or IEC 60601-1:2012 reprint. All the results presented here demonstrated general requirements for basic safety and essential performance.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to IEC 60601-1-2: 2007 (Third Edition). All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- PALLAS 308/311 Solid-State UV Laser System is tested according to IEC 60601-1-6:2010. AMD1:2013
- PALLAS 308/311 Solid-State UV Laser System 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 to IEC 60825-1: 2014 (Third Edition). All the results presented here demonstrated the equipment classification and requirements.
- Risk management was recorded according to ISO 14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
- Usability was documented according to ISO 14971: 2012 and IEC 62366. All the results presented here demonstrated the application of risk management to medical devices.
- Software Validation was reported according to IEC 62304 Edition 1.1 2015-06 -CONSOLIDATED VERSION
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Laseroptek Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bangkok, 10160 Th
Re: K191501
Trade/Device Name: PALLAS 308/311 Solid-State UV 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 12, 2019 Received: December 13, 2019
Dear Paweena U-Thainual:
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.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Mavadia-Shukla Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191501
Device Name
PALLAS 308/311 Solid-State UV Laser System
Indications for Use (Describe)
The indication for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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3
5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | #116, #117, #203, #204 Hyundai I Valley, 31 |
| Galmachi-ro, 244beon-gil, Jungwon-gu | |
| Seongnam-Si, Gyeonggido, 13212 | |
| Rep. of Korea (South Korea) | |
| Contact Person: | Paweena U-Thainual |
| Address: | MDR Solutions Co., Ltd. |
| 1435 Kanchanapisek Rd., Bang Khae Nuea, | |
| Bang Khae, Bangkok 10160, THAILAND | |
| Tel: +66-2-804-2101 Fax: +66-2-804-2100 | |
| Email: paweena@mdrsolutions.co.th | |
| Preparation Date: | June 5th, 2019 |
2. Device Name and Code
| Device Trade Name: | PALLAS 308/311 Solid-State UV Laser System |
|---|---|
| Common Name: | UV 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. Technical Characteristics in Comparison to Predicate Devices
Predicate Device: K172639 - PALLAS 308/311 Solid-State UV Laser System, Laseroptek Co., Ltd.
Technical characteristic changes in comparison of modified device to unmodified device were specified in following table.
| Unmodified/Predicate Device | Modified/Proposed Device | |
|---|---|---|
| 510(K) Number | K172639 | N/A |
| Manufacturer | Laseroptek Co. Ltd. | Laseroptek Co. Ltd. |
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| Device Name | PALLAS Solid-State UV Laser System | PALLAS Solid-State UV Laser System |
|---|---|---|
| Clearance Date: | November 3, 2017 | N/A |
| Classification / | ||
| Regulation | Class 2 / 878.4810 | Class 2 / 878.4810 |
| Product Code | GEX | GEX |
| Intended Use | UVB phototherapy of psoriasis, vitiligo, | |
| atopic dermatitis, and leukoderma of | ||
| affected skin. | UVB phototherapy of psoriasis, vitiligo, | |
| atopic dermatitis, and leukoderma of | ||
| affected skin. | ||
| Mode of | ||
| Operation | Monochromatic UVB Phototherapy | Monochromatic UVB Phototherapy |
| Wavelength | 308 nm or 311 nm | 308 nm or 311 nm |
| Output: | ||
| Beam Profile | Flat-top, Non-Gaussian | Flat-top, Non-Gaussian |
| Maximum Pulse | ||
| Duration | 15 to 20 ns | 15 to 20 ns |
| Output Energy | ||
| per Pulse | Up to 4.2 mJ | 5.0 mJ |
| Fluence per | ||
| pulse (mJ/cm²) | 3.5 - 4.4 $mJ/cm^2$ | 3.47 $mJ/cm^2$ |
| Physical | ||
| Characteristics: | ||
| Activation | Via foot-switch | Via foot-switch |
| Cooling system | Radiator | Chiller |
| Electrical | ||
| Requirements | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz |
| Maximum Power | 20W | 20W |
510(k) Summary
4. Device Description
Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.
5. Indications / Intended Use
UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
6. Performance Data
Non-clinical tests: Measurement of wavelength, average output power, and energy fluence (in units of mW/cm2) of treatment were performed. Testing conducted on the PALLAS 308/311 Solid-State UV 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 consensus standards:
5
510(k) Summary
- -PALLAS 308/311 Solid-State UV Laser System is tested and evaluated according to IEC 60601-1:2005 (Third Edition) + CORR.1:2006+ CORR. 2:2007 + A1:2012 or IEC 60601-1:2012 reprint. All the results presented here demonstrated general requirements for basic safety and essential performance.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to IEC 60601-1-2: 2007 (Third Edition). All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -PALLAS 308/311 Solid-State UV Laser System is tested according to IEC 60601-1-6:2010. AMD1:2013
- PALLAS 308/311 Solid-State UV Laser System 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 to IEC 60825-1: 2014 (Third Edition). All the results presented here demonstrated the equipment classification and requirements.
- -Risk management was recorded according to ISO 14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
- -Usability was documented according to ISO 14971: 2012 and IEC 62366. All the results presented here demonstrated the application of risk management to medical devices.
- Software Validation was reported according to IEC 62304 Edition 1.1 2015-06 -CONSOLIDATED VERSION
The portion of the device that touches patient body is made of aluminum alloy 6061, which have been used for other medical devices without any biocompatibility risk.
7. Substantial Equivalence
The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use and material. The differences are in hand-piece tip shape, output energy, and cooling system. However, the performance test shown that there is no technical characteristic difference in the modified device. The change in output energy does not raise any concerns regarding the device performance and safety as shown in Section 6. Performance Data. Therefore, PALLAS 308/311 Solid-State UV Laser System is substantially equivalence to the legally marketed unmodified/predicate device.
8. Conclusions
On the basis of the information provided in this Summary, Laseroptek Co., Ltd. Believes that PALLAS 308/311 Solid-State UV Laser System is substantially equivalent to legally marketed unmodified/predicate device.