(171 days)
WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
The WON Technology's Pastelle Q-Switched Nd:YAG Laser uses a Nd: YAG material to generate the Qswitching laser. The device is comprised of a main body, articulated arm, foot switch and ancillary accessories. This device is designed to provide laser energy for use in a variety of dermatological procedures. The 532nm and 1064nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very broad laser pulses (6-20ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
The WON Technology Pastelle Q-Switched Nd:YAG Laser (K123293) did not conduct a clinical study. Instead, its performance was evaluated through a comparison of its technological characteristics with a legally marketed predicate device, the Continuum-Electro Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser (K014234). The device also underwent bench testing, which included software validation, electrical safety, electromagnetic compatibility, transit testing, and functional testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate: MedLite C6 K014234) | Reported Device Performance (Pastelle K123293) |
|---|---|---|
| Laser Type | Q-Switched Nd:YAG | Q-Switched Nd:YAG |
| Wavelength | 532nm, 1064nm | 532nm, 1064nm |
| Pulse | Single, 1, 2, 5 and 10Hz | Single, 0-10Hz ±20% |
| Pulse duration | 5 to 20ns | 6 to 20ns |
| Power Requirement | 220V AC, 50/60Hz; 110V AC, 50/60Hz | 220V-230V AC, 50/60Hz |
| Spot size | 3, 4, 6, 8mm at 1064nm; 2, 3, 4, 6mm at 532nm | 2mm to 10mm; Control value: 1mm |
| Energy per pulse (MAX) | 1000mJ at 1064nm; 400mJ at 532nm | 1300mJ at 1064nm; 500mJ at 532nm |
2. Sample size used for the test set and the data provenance:
No clinical test set was used for this device. The evaluation was based on a comparison of technological specifications and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set was used.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was used.
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, as no MRMC study or AI component was involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a laser device, not an algorithm.
7. The type of ground truth used:
For the comparison of technological characteristics, the ground truth was the published specifications of the legally marketed predicate device (Continuum Electro-Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser, K014234). For the bench studies, the ground truth was the expected functional performance and compliance with relevant safety and electromagnetic compatibility standards.
8. The sample size for the training set:
Not applicable, as this device does not involve a training set as it's not an AI/ML-based device.
9. How the ground truth for the training set was established:
Not applicable.
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K 123293
Section 5 510(k) Summary
APR 1 1 2013
In accordance with 21 CFR 807.92 (Summary):
A summary of the information regarding the safety and effectiveness of the Pastelle Laser System, as required by the Safe Medical Device Amendments of 1990, is provided as follows:
510(k) Summary for the WON Technology Co., Ltd. Pastelle Q-Switched Nd: YAG Laser
-
- Applicant: WON Technology Co., Ltd. WON Technology Co., Ltd. 2. Address: 64 Techno 8-ro Yuseong-gu, Daejeon Republic of Korea 3. Contact Person: Young-Seok Seo (The director of WON Technology Laboratory) +82-42-934-6800 4. Telephone: +82-42-934-9491 Fax: E-mail: physys@wtlaser.com 5. Preparation Date: October 17, 2012 6. Device Trade Name: Pastelle 7. Common Name: Nd:YAG Laser 8. Classification Name: Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery 9. Legally Marketed Continuum-Electro Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser Predicate Device: (K014234)
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10. Description of the WON Technology Pastelle Q-Switched Nd:YAG Laser:
- Intended use of the WON Technology Q-Switched Laser:
12. Performance Data:
- Results of Clinical Study:
Lutronic Spectra VRMII(K080248) HOYA Conbio RevLite Q-Switched Nd: YAG Laaser System (K083899)
The WON Technology's Pastelle Q-Switched Nd:YAG Laser uses a Nd: YAG material to generate the Qswitching laser. The device is comprised of a main body, articulated arm, foot switch and ancillary accessories.
This device is designed to provide laser energy for use in a variety of dermatological procedures. The 532nm and 1064nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect.
The laser incorporates very broad laser pulses (6-20ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
WON Technology's Pastelle Q-Switched Nd:YAG Laser System is a indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coaqulation and Hemostasis.
Bench studies indicate that the Pastelle device performs as intended. The following bench testing was performed: software validation, electrical safety, electromagnetic compatibility, transit testing and functional testing.
No clinical studies were performed.
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| WON TechnologyPastelle Q-SwitchedNd:YAG Laser K123293 | Continuum Electro-Optics, Inc. MedLite C6Q-Switched Nd:YAGLaser K014234 | |
|---|---|---|
| Laser Type | Q-Switched Nd:YAG | Q-Switched Nd:YAG |
| Wavelength | 532nm, 1064nm | 532nm, 1064nm |
| Pulse | Single,0-10Hz ±20% | Single,1, 2, 5 and 10Hz |
| Pulse duration | 6 to 20ns | 5 to 20ns |
| Power requirement | 220V-230V AC, 50/60Hz | 220V AC, 50/60Hz110V AC, 50/60Hz |
| Spot size | 2mm to 10mmControl value: 1mm | 3, 4, 6, 8mm at 1064nm2, 3, 4, 6mm at 532nm |
| Energy per pulse(MAX) | 1300mJ at 1064nm500mJ at 532nm | 1000mJ at 1064nm400mJ at 532nm |
*Summary of Technological Characteristics:
서 약
(Signature of Certifier)
Young-Seok Seo (Director of WON Technology Laboratory) (Typed Name)
October 17, 2012
(Date)
*Pre-market Notification 510(k)
*For a new submission, leave the 510(k) number blank.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is composed of three stylized, curved lines that resemble a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
WON Technology Co., Ltd. % Northwest Clinical Research Group, Inc. Roberta Hines. President and CEO 24125 8th Avenue Southeast Woodinville, Washington 98052
April 11, 2013
Re: K123293
Trade/Device Name: Pastelle O-Switched Nd: Y AG Laser 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: March 05, 2013
Received: March 18, 2013
Dear Ms. Hines:
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. Isting 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
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Page 2 - Roberta Hines, President and CEO
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number (if known): K123293
Device Name: Trade Name, Pastelle
Indications for Use
WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.04.08 1:6:06:14 -04'00'
Division Sign-Off for MXM Division of Surgical Devices Office of Device Evaluation 510(k) Number: K123293
§ 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.