(56 days)
Not Found
No
The summary describes a laser system controlled by a microprocessor, but there is no mention of AI, ML, or related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma."
No
Explanation: The "Intended Use / Indications for Use" section states that the device is for "treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly details hardware components such as a power supply unit, cooling system, controller, laser resonator, flash lamp, and optical fiber. The performance studies also include testing related to hardware safety and electromagnetic compatibility. While software verification and validation are mentioned, the device is clearly a physical laser system with integrated software, not a standalone software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma." This describes a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a laser system designed to emit UV light for direct application to the patient's skin. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or providing information about a patient's health status based on such analysis, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly treats a condition on the patient's body.
N/A
Intended Use / Indications for Use
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311mm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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: Such as safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:
- Basic safety and essential performance of the PALLAS Premium is tested and evaluated according to the FDA-recognized consensus standard, AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
- Safety of laser product is evaluated in accordance with IEC 60825-1.
- Basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment is evaluated in accordance with IEC 60601-2-22:2019.
- Risk management was recorded by referring to ISO 14971.
- Usability was documented by referring to IEC 60601-1-6.
- Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator.
Biocompatibility testing for PALLAS Premium was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on Sep. 4. 2020 and International Standard ISO 10993-5:2009 and ISO 10993-10:2010.
Biocompatibility testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 26, 2023
Laseroptek Co., Ltd. % Wonmi Lee Manager BT Solutions. Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South
Re: K223588
Trade/Device Name: PALLAS 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: November 30, 2022 Received: December 1, 2022
Dear Wonmi Lee:
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.
1
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 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.
Jianting Wang -S
Jianting Wang 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
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Indications for Use
510(k) Number (if known) K223588
Device Name PALLAS Premium
Indications for Use (Describe)
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K223588 PALLAS Premium 510(k) Summary
6. 510(k) Summary
6.1 General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | #114, #116, #117, #203, #204 Hyundai I |
| Valley ,31, Galmachi-Ro, 244beon-gil, | |
| Jungwon-Gu, Seongnam-Si, Gyeonggi-do, | |
| 13212, Rep. of Korea (South Korea) | |
| Contact Person: | Wonmi Lee, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5, |
| Gangnam-gu, Seoul 06210, Korea. | |
| Tel: +82-2-538-9140 | |
| Email: wmlee@btsolutions.co.kr | |
| Preparation Date: | January 26, 2023 |
6.2 Device Name and Code
| Device Trade Name: | PALLAS Premium |
|---|---|
| Common Name: | Solid-State UV Laser (Nd:YAG laser crystal) |
| 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 |
6.3 Technical Characteristics in Comparison to Predicate Devices
The PALLAS Premium, is the same or similar with the following legally marketed predicate devices:
| | Predicate Device 1 | Proposed Device | Same or
Similar |
|--------------------------------|------------------------------------------------|------------------------------|--------------------|
| 510(K)
Number | K191501 | Not Available | |
| Manufacturer | Laseroptek Co., Ltd. | Laseroptek Co. Ltd. | |
| Device Name | PALLAS 308/311 Solid-
State UV Laser System | PALLAS Premium | |
| Product Code | GEX | GEX | YES |
| Classification /
Regulation | Class II/
21 CFR 878.4810 | Class II/
21 CFR 878.4810 | YES |
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510(k) Summary Laser type Solid-State UV Laser Solid-State UV Laser YES (Nd:YAG laser crystal) (Nd:YAG laser crystal) UV Spectrum UVB UVB YES Wavelength 308 nm or 311 nm 308 nm or 311 nm YES Pulse Duration 15 to 20 ns 20 ns YES (Max.) Pulse Energy Up to 5.0 mJ Up to 5.0 mJ YES (Max.) Fluence 3.47 mJ/cm² 3.47 mJ/cm² yes (Max.) Repetition rate 100 Hz 300 Hz YES Spot size 12 x 12 mm 12 x 12 mm YES 15 x 15 mm 18 x 18 mm Intended Use / psoriasis psoriasis YES Indications for vitiligo vitiligo Use atopic dermatitis atopic dermatitis leucoderma leucoderma Other N/A Characteristics: Articulated arm with Articulated arm with Beam Delivery YES System handpiece handpiece Interface User interface control User interface control yes display display
K223588 PALLAS Premium
Table 1. Comparison of the predicate device 1(K191501) and PALLAS Premium
| | Predicate Device 2 | Proposed Device | Same or
Similar |
|--------------------------------|----------------------------------------------------------|------------------------------------------------|--------------------|
| 510(K)
Number | K193478 | Not Available | |
| Manufacturer | Strata Skin Sciences, Inc. | Laseroptek Co. Ltd. | |
| Device Name | XTRAC Momentum
Excimer Laser System,
Model AL10000 | PALLAS Premium | |
| Product Code | GEX | GEX | YES |
| Classification /
Regulation | Class II/
21 CFR 878.4810 | Class II/
21 CFR 878.4810 | YES |
| Laser type | XeCl Excimer laser | Solid-State UV Laser
(Nd:YAG laser crystal) | N/A* |
| UV Spectrum | UVB | UVB | YES |
| Wavelength | 308 nm | 308 nm or 311 nm | YES |
| Pulse Duration
(Max.) | 30 ns | 20 ns | YES |
| Pulse Energy
(Max.) | Up to 15 mJ | Up to 5.0 mJ | YES |
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| PALLAS Premium | |||
|---|---|---|---|
| 510(k) Summary | |||
| Fluence | |||
| (Max.) | 3.8 mJ/cm² | 3.47 mJ/cm² | YES |
| Repetition | |||
| Rate | |||
| (Max.) | 400 Hz | 300 Hz | YES |
| Spot size | 20 x 20 mm | 12 x 12 mm | |
| 15 x 15 mm | |||
| 18 x 18 mm | YES | ||
| Intended Use / | |||
| Indications for | |||
| Use | psoriasis | ||
| vitiligo | |||
| atopic dermatitis | |||
| leucoderma | psoriasis | ||
| vitiligo | |||
| atopic dermatitis | |||
| leucoderma | YES | ||
| Other | |||
| Characteristics: | N/A | ||
| Beam Delivery | |||
| System | Liquid fiber-optic (LLG) | ||
| with user-directed hand | |||
| piece | Articulated arm with | ||
| handpiece | YES | ||
| Interface | User interface control | ||
| display | User interface control | ||
| display | YES |
Table 2. Comparison of the predicate device 2(K193478) and PALLAS Premium
6.4 Device Description
This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311mm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.
6.5 Indications / Intended Use
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
6.6 Performance Data
Non-clinical tests: Such as safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:
- Basic safety and essential performance of the PALLAS Premium is tested and evaluated according to the FDA-recognized consensus standard, AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012.
- -Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
- Safety of laser product is evaluated in accordance with IEC 60825-1. -
- -Basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment is evaluated in accordance with IEC 60601-2-22:2019.
- -Risk management was recorded by referring to ISO 14971.
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K223588 PALLAS Premium
510(k) Summary
- Usability was documented by referring to IEC 60601-1-6. -
- -Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator.
6.7 Biocompatibility testing
The biocompatibility evaluation for PALLAS Premium was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on Sep. 4. 2020 and International Standard ISO 10993-5:2009 and ISO 10993-10:2010.
Biocompatibility testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
PALLAS Premium is considered skin contacting for a duration of less than 24 hours. The contact is for the support of the device when in treatment, not for the treatment itself. All the materials used that contact patient skin are Aluminum alloy 6061.
6.8 Conclusions
The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for PALLAS 308/311 Solid-State UV Laser System, Laseroptek Co., Ltd., and XTRAC Momentum Excimer Laser System, Model AL10000, Strata Skin Sciences, Inc., Laseroptek Co., Ltd. believes that no significant differences in usage of its underlying technological principles between PALLAS Premium and the predicate devices.
On the basis of the information provided in this Summary. Laseroptek Co. Ltd. Believes that PALLAS Premium is the same or similar with legally commercialized predicate devices for the purposes of this 510(k) submission.