(134 days)
Not Found
No
The device description focuses on laser technology and a microprocessor for selecting wavelengths and parameters. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is described as treating various medical conditions such as vascular lesions, pigmented lesions, and is used for incision, excision, ablation, and vaporization of soft tissue in general dermatology, which are all therapeutic activities.
No
The device description and intended use indicate that it is a therapeutic device used for various dermatological treatments (e.g., tattoo removal, treatment of vascular and pigmented lesions, incision, excision), not for diagnosing conditions.
No
The device description clearly outlines a hardware-based laser system with physical components like an optical cavity, crystals, flashlamp, articulated arm, and handpiece. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this is a laser system used for treating various skin conditions and removing tattoos by directly interacting with the soft tissue. It is an external treatment device, not a device that analyzes samples taken from the body.
- Intended Use: The intended uses listed (Tattoo Removal, Treatment of Vascular Lesions, Treatment of Pigmented Lesions, Incision, Excision, Ablation, Vaporization of Soft Tissue) are all therapeutic procedures performed directly on the patient's skin.
- Device Description: The description details the laser technology, wavelengths, and delivery system, all of which are consistent with a therapeutic laser device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Tattoo Removal
- Treatment of Vascular Lesions
- Treatment of Pigmented Lesions,
- Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
1064nm:
Tattoo Removal: Dark ink: blue and black
Treatment of Pigmented Lesions: Nevus of ota
532nm:
Tattoo Removal: Light ink: red, Light ink: sky blue and green
Treatment of Vascular Lesions: Port wine birthmarks, Telangiectasias, Spider angioma, Cherry angioma, Spider nevi
Treatment of Pigmented Lesions: Café-au-lait birthmarks, Solar lentiginos, Senile lentiginos, Becker's nevi, Freckles, Nevus spilus
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.
Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy, spot size, fluence via control panel.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing was conducted to validate and verify that the proposed device, QMetrx1000 (Victory-11) Nd: YAG Laser System met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required.
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
FEB 2 8 2014
510(k) Summary
Nd: YAG Laser System Beijing Toplaser Technology Co., Ltd. (As required by 21 CFR 807.92) K Number: K133158
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Date Prepared: Sep. 22, 2013
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Sponsor Information Beijing Toplaser Technology Co., Ltd. East 30 Floor, Building M7, No.1 Jiuxianqiao East Road, Chaoyang District, Beijing 100015, China Contract Person: Zhang Xiaosong, General Manager Phone: +86-10-64354759 Fax: +86-10-64356591
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Proposed Device Information Device Common or Usual Name: Nd: YAG Laser Device Trade or Proprietary Name: Qmetrx 1000 (Victory 11) Nd: YAG Laser System Classification Name: Laser instrument, Surgical, Powered Regulation Number: 21 CFR 878.481 0 Product Code: GEX Panel: General and Plastic Surgery Model: QMetrx1000 (Victory-11)
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Predicate Device Medlite C6 Q-Switched Nd: YAG Laser (K014234) Medlite™ C3 Q-Switched Nd: YAG Laser (K011677) Manufactured by Continuum Electro-Optics, Inc.
5. Device Description
The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP
1
Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.
Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy ,spot size ,fluence via control panel.
- Intended use and Indications of Use
- · Tattoo Removal
- · Treatment of Vascular Lesions
- · Treatment of Pigmented Lesions,
• Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
1064nm | 532nm |
---|---|
Tattoo Removal | Tattoo Removal |
Dark ink: blue and black | Light ink: red Light ink: sky blue and green |
Treatment of Pigmented Lesions | Treatment of Vascular Lesions |
Nevus of ota | Port wine birthmarks Telangiectasias Spider angioma Cherry angioma Spider nevi |
Treatment of Pigmented Lesions | |
Café-au-lait birthmarks Solar lentiginos Senile lentiginos Becker's nevi Freckles Nevus spilus |
7. Substantial Equivalence
The product Nd:YAG Laser System, model QMetrx1000(Victory-11) shares the similar indications for use, design features, functional features, same safety compliance. Therefore the product Nd:YAG Laser System, model
2
QMetrx1000(Victory-11) is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
8. Testing
The Nd: YAG Laser System is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
IEC 60825-1: Safety of laser products - Part 1: Equipment classification, . requirements and user's quide.
IEC 60601-2-22: Medical Electrical Equipment - Part 2: Particular . requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60601-1: Medical Electrical Equipment - Part 1: General requirements . for safety.
IEC 60601-1-2: Medical Electrical Equipment -Part 1: General requirements . for safety-2, Collateral Standard: Electromagnetic compatibility - Requirements and tests.
UL 60601-1:2003 R6.03 .
Non-Clinical Conclusion:
Laboratory testing was conducted to validate and verify' that the proposed device, QMetrx1000(Victory-11) Nd: YAG Laser System met all design specifications and was substantially equivalent to the predicate device. No Clinical Information is required.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Beijing Toplaser Techonology Company, Ltd. Mr. Zhang Xiaosong General Manager East 3rd Floor, Building M7, No. 1 Jiuxianqiao East Road Chaoyang District, Beijing 100015 CHINA
Re: K133158
Trade/Device Name: Ometrx 1000 (Victory 11) Nd: YAG 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 28, 2013 Received: December 2, 2013
Dear Mr. Xiaosong:
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
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Page 2 - Mr. Zhang Xiaosong
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Felipe Aguel
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K133158
Device Name: Qmetrx 1000 (Victory 11) Nd: YAG Laser System Indications For Use:
- · Tattoo Removal
- · Treatment of Vascular Lesions
- · Treatment of Pigmented Lesions,
- · Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
1064nm | 532nm |
---|---|
Tattoo Removal | Tattoo Removal |
● Dark ink: blue and black | ● Light ink: red |
● Light ink: sky blue and green | |
Treatment of Pigmented Lesions | Treatment of Vascular Lesions |
● Nevus of ota | ● Port wine birthmarks |
● Telangiectasias | |
● Spider angioma | |
● Cherry angioma | |
● Spider nevi | |
Treatment of Pigmented Lesions | |
● Café-au-lait birthmarks | |
● Solar lentiginos | |
● Senile lentiginos | |
● Becker's nevi | |
● Freckles | |
● Nevus spilus |
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use YES (Part 21 CFR 801 Subpart D) (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) Felipe Aguel Date: 2014.02.28
14:20:51 -05'00'
(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Page 1 of ____________________________________________________________________________________________________________________________________________________________________