(8 days)
Not Found
No
The document describes a laser system with specific wavelengths and pulse durations for tissue treatment. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for the treatment of various medical conditions, including tattoo removal, pigment lesions, vascular lesions, and skin resurfacing procedures for acne scars and wrinkles. These are procedures for medical conditions, not general wellness.
No
The device is indicated for therapeutic procedures such as incision, excision, ablation, vaporization of soft tissues, and removal of tattoos and lesions, rather than for diagnosing conditions.
No
The device description explicitly states it is a "Q-Switched Nd: YAG Laser System" and lists hardware components such as a power supply, laser emission and delivery system, and cooling system. This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed on the patient's body (incision, excision, ablation, vaporization of soft tissues, tattoo removal, lesion removal, etc.). IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to diagnose or monitor conditions.
- Device Description: The description details a laser system designed to deliver energy to the skin and soft tissues. This is consistent with a therapeutic or surgical device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Q-Switched Nd: YAG Laser System is a therapeutic/surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions
Treatment of Lentigines
Treatment of Caf6-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos
Removal of Nevus of Ota
Removal of lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Q-Switched Nd: YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.
The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
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 verity that the proposed device Q-Switched Nd: Y AG Laser System (GlobalCure-SC6) met all design specifications and was substantially equivalent to the predicate device.
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
Section III. 510(K) Summary
JUL 2 5 2010
Q-Switched Nd:YAG Laser System Advanced Technology Laser Co., Ltd
(As required by 21 CFR 807.92)
-
- Date Prepared: March 22, 2010
2. Sponsor Information:
Advanced Technology Laser Co., Ltd 920 Jian-chuan Road, Bldg. A2, Level 5 Shanghai, 200240, China
Contact Person: Mingxia Xi, Director for Regulatory Affairs Phone: +86-21-54712151 Fax: +86-21-54712152
3. Submission Correspondent
Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China Tel: +86-21-64264467 Fax: +86-21-64264467-809 Email: Diana.hong@mid-link.net
-
- Proposed Device Information
1
DVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - 510(k) Summary Device Common or Usual Name: O-Switched Nd: YAG Device Trade or Proprietary Name: Q-Switched Nd: YAG Laser System Model: GlobalCure-SC6 Classification Name: Laser Instrument, Surgical, Powered; Regulation Number: 21 CFR 878.4810; Product Code: GEX Panel: 878 General and Plastic Surgery
5. Predicate Device
Spectra VRMII (O-Switched Nd: YAG) (K073436)
6. Device Description
The Q-Switched Nd: YAG Laser System is a new device for 510(k) submission and shares the same indications for use and safety compliance, similar design features and functional features with the predicate device.
The Q-Switched Nd:YAG Laser System (GlobalCure-SC6) delivers laser at two wavelengths of 1064nm and 532nm. The double wavelengths cause maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target. to minimize heat transfer to surrounding tissues.
The Q-Switched Nd:YAG Laser System covers control system, user interface, power supply, laser emission and delivery system, cooling system and safety features.
7. Indications for use
The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions
2
VANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - 510(k) Summary
Treatment of Lentigines
Treatment of Caf6-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos
Removal of Nevus of Ota
Removal of lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
8. Substantial Equivalence
The Q-Switched Nd:YAG Laser System shares the same indications for use and safety compliance, similar design features, functional features, and therefore are substantially equivalent to the predicate device, Spectra VRMII (O-Switched Nd:YAG) (K073436). In addition, a review of the predicate device demonstrates that the O-Switched Laser System is safe and effective as the predicate device as they share equivalent wavelengths, and are used to perform the same indicated surgical procedures. Therefore the proposed device is substantially equivalent (SE) to the predicate device.
9. Testing
The Q-Switched Nd: YAG Laser System (GlobalCure-SC6) is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including:
- IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements and user's guide.
- . IEC 60601-2-22:1995, Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- 0 IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Part 1: General requirements for safety.
3
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report - 510(k) Summary
IEC60601-1-2:2001+A1:2004, Medical Electrical Equipment - Part 1: General requirements for safety-2, Collateral Standard: Electromagnetic compatibility -Requirements and tests.
The devices also comply with European Medical Directive 93/42/EEC and the US Federal Performance Standards 21 CFR 1002.10 Requirements (21CFR 1040.10 and 21CFR 1040.11 for Class IV Laser Products), Part 820 - Quality System Regulation, and have passed ISO9001 and ISO13485 System Certification.
Non-Clinical Conclusion:
Laboratory testing was conducted to validate and verity that the proposed device Q-Switched Nd: Y AG Laser System (GlobalCure-SC6) met all design specifications and was substantially equivalent to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, graphic style.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Technology Laser Co., Ltd. % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, New York 11747
Received: July 21, 2010
UUL Z 5 2010
Re: K102050
Trade/Device Name: Q-Switched 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: II Product Code: GEX Dated: July 9, 2010
Dear Mr. Conry:
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 (reporting of medical
5
Page 2 - Ms. Julie Acker, RAC
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ucm115809.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 tc
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 vours.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
6
ADVANCED TECHNOLOGY LASER CO., LTD. 510(k) Submission Report -Indications for Use Statement
K102050
Section II. Indications for Use Statement
JUL 2 9 2010
510(k) Number:
Device Name:
Q-Switched Nd: YAG Laser System
Indications for Use:
The Q-Switched Nd: YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos
Removal of Epidermal Pigmented Lesions
Removal of Minor Vascular Lesions
Treatment of Lentigines
Treatment of Caf6-Au-Lait
Treatment of Seborrheic Keratoses
Treatment of Post Inflammatory Hyper-Pigmentation
Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos
Removal of Nevus of Ota
Removal of lightening of unwanted hair with or without adjuvant preparation
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
Prescription Use __ X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melkerson
Page 1 of 1
11-1
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number