(63 days)
No
The description focuses on the laser technology and its delivery system, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML.
Yes
The device description and intended use clearly state that it provides "UVB phototherapy" for various skin conditions, indicating a therapeutic purpose. Furthermore, "therapeutic" is explicitly mentioned in one of the performance standards (IEC 60601-2-22) the device was tested against.
No
This device is described as a UV laser system for phototherapy, intended for the treatment of skin conditions, not for diagnosis.
No
The device description clearly outlines a hardware system including a console, hand piece, and articulating arm, which delivers UV laser light. While it has a user interface controlled by a display, the core functionality and delivery are hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "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 consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
- Performance Studies: The performance studies focus on the device's physical characteristics (wavelength, power, energy fluence) and compliance with safety and performance standards for laser and medical devices. They do not involve the analysis of biological samples or diagnostic accuracy metrics.
- Predicate and Reference Devices: The predicate and reference devices listed are also phototherapy systems and laser systems used for treatment, further supporting the conclusion that this is a therapeutic device.
In summary, the device's function is to deliver therapeutic UV light to the skin for the treatment of specific conditions, which is the definition of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
Product codes
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
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 + CORR.1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1:2012. 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 the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- 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 FDA-recognized consensus standard IEC 60825-1: 2007. 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 ISO -14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 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.
November 3, 2017
Laseroptek Co. Ltd % Mr. Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K172639
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: October 25, 2017 Received: October 26, 2017
Dear Mr. Yungvirt:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) 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@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -ડિ
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
2
Indications for Use
510(k) Number (if known) K172639
Device Name
PALLAS 308/311 Solid-State UV Laser System
Indications for Use (Describe)
The indications 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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5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | #203 & #204 Hyundai I Valley 31 |
| Galmachi-Ro, Jungwon-Gu | |
| Seongnam-Si, Gyeonggido, 13212 | |
| Rep. of Korea (South Korea) | |
| Tel) +82.31.8023.5150 | |
| Fax) +82.31.8023.5151 | |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 502, 148 Yuksamro, Gangnam-gu, Seoul, |
| Republic of Korea | |
| Tel) +82.2.538.9140 | |
| Email) smanager@btsolutions.co.kr | |
| Preparation Date: | August-30-2017 |
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
PALLAS 308/311 Solid-State UV Laser System is substantially equivalent to the following legally marketed predicate devices
| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| 510(K) Number | K020847 | K062963 | Not Available |
| Manufacturer | PhotoMedex, Inc. | RA Medical Systems, Inc. | Laseroptek Co. Ltd. |
| Device Name | XTrac Excimer Laser | ||
| System, Model AL7000 | PHAROS Excimer Laser | ||
| EX-308 | PALLAS Sold-State UV | ||
| Laser System |
4
PALLAS 308/311 Solid-State UV Laser System
| Clearance Date: | 16 May 2002 | April 3, 2007 | N/A |
|---|---|---|---|
| Classification / | |||
| Regulation | Class 2 / 878.4810 | Class 2 / 878.4810 | Class 2 / 878.4810 |
| Product Code | GEX | GEX | GEX |
| Intended Use | UVB phototherapy for | ||
| psoriasis, vitiligo, atopic | |||
| dermatitis, and leukoderma. | UVB phototherapy for | ||
| psoriasis, vitiligo, atopic | |||
| dermatitis, and leukoderma. | UVB phototherapy for | ||
| psoriasis, vitiligo, atopic | |||
| dermatitis, and leukoderma. | |||
| Mode of | |||
| Operation | Monochromatic UVB | ||
| Phototherapy | Monochromatic UVB | ||
| Phototherapy | Monochromatic UVB | ||
| Phototherapy | |||
| Wavelength | 308 nm | 308 nm | 308 nm or 311 nm |
| Pulse | |||
| Characteristics: | |||
| Maximum Pulse | |||
| Duration | 30 ns | 20 to 50 ns | 15 to 20 ns |
| Output Energy | |||
| per Pulse | 15 mJ | Up to 15 mJ Max | Up to 4.2 mJ |
| Fluence per | |||
| pulse (mJ/cm²) | 2 to 3.8 mJ/cm² | 2 to 5 mJ/cm², 3 mJ/cm² | 3.5 - 4.4 mJ/cm² |
| Physical | |||
| Characteristics: | |||
| Activation | Via foot-switch | Via foot-switch | Via foot-switch |
| Beam Profile | Flat-Top, Non-Gaussian | Flat-Top, Non-Gaussian | Flat-Top, Non-Gaussian |
| Electrical | |||
| Requirements | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz |
| Maximum Power | 20W | 20 W | 20W |
510(k) Summary
Reference Devices: TheraLight, Inc.'s UV120-2 UVA/UVB Phototherapy System . (K024020) *
*This reference device is referred to technical aspects, of which Narrow Band (NB) UVB lamps are used and emit UVB pulsed energy at the nominal center wavelength of 311 nm the same to those of the PALLAS 308/311 Solid-State UV Laser System.
- Laseroptek Co. Ltd.'s Helios III Q-Switched Nd: Y AG Laser o System (K152856) **
**This reference device is referred, of which hand piece's material are the same to those of the PALLAS 308/311 Solid-State UV Laser System.
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
5
510(k) Summary
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 for 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:
- PALLAS 308/311 Solid-State UV Laser System is tested and evaluated according to IEC -60601-1:2005 + CORR.1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1:2012. 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 the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- 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 FDA-recognized consensus standard IEC 60825-1: 2007. 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 ISO -14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
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 intended use of the PALLAS 308/311 UV Laser System is within the scope of the predicate devices. PALLAS 308/311 UV Laser System, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the PALLAS 308/311 UV Laser System, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying
6
technological principles between PALLAS 308/311 UV Laser System and the cited predicate devices.
8. Conclusions
On the basis of the information provided in this Summary, Laseroptek Co., Ltd. Believes that PALLAS 308/311 UV Laser System is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.