(147 days)
No
The document describes a laser system and its various handpieces for different dermatological and cosmetic treatments. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML in the device's operation or decision-making. The description focuses on the physical characteristics and parameters of the laser system.
Yes
The device is indicated for the treatment of various medical conditions such as vascular lesions, pseudofolliculitis barbae, benign pigmented lesions, and wrinkles, which falls under the definition of a therapeutic device.
No
Explanation: The device is indicated for surgical, aesthetic, and cosmetic applications, including treatment of various lesions, hair removal, and wrinkle treatment. It is a therapeutic device, not a diagnostic one, as its purpose is to treat conditions rather than to identify or analyze them.
No
The device is described as a "Laser System" with "Handpieces" that deliver "laser energy" and are "water-cooled". This clearly indicates the presence of physical hardware components that are integral to the device's function, not just software.
Based on the provided text, 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.
- Device Function: The ADVANTAGE Laser System is a laser device that delivers energy to the body for surgical, aesthetic, and cosmetic applications. It directly interacts with the patient's tissue.
- Intended Use: The intended uses listed are all related to treating conditions or performing procedures directly on the patient's body (e.g., hair removal, vascular lesion treatment, wrinkle treatment).
- No mention of samples: The description and intended use do not mention analyzing any samples taken from the body.
Therefore, the ADVANTAGE Laser System is a therapeutic and aesthetic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins.
The ADVANTAGE Laser System with D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions. The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Product codes
GEX
Device Description
The ADVANTAGE Laser System with D1-1064 Handpiece is a treatment handpiece, intended to be used with ADVANTAGE Laser System 510(k) cleared in K113502 on April 5, 2012. The ADVANTAGE Laser System with D1-1064 Handpiece delivers laser energy through a 10 x 10 mm tip with a fluence of up to 100 J/cm2. The settings for this handpiece are pulse duration from 5-400 msec, and a pulse repetition rate up to 3 Hz maximum. The ADVANTAGE Laser System with D1-1064 Handpiece is water-cooled to provide active skin cooling.
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
medical specialties of general and plastic surgery, and dermatology.
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)
None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Lutronic Corporation Dr. Jhung Won Vojir Global Regulatory Officer 6 Neshaminy Interplex, Suite 100 Trevose, Pennsylvania 19053
Re: K141555
Trade/Device Name: ADVANTAGE 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 10, 2014 Received: October 14, 2014
Dear Dr. Jhung Won Vojir:
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
1
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 (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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,
David Krause -S
- 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
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Indications for Use
510(k) Number (if known):
Device Name: ADVANTAGE Laser System
Indications for Use:
The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins.
The ADVANTAGE Laser System with D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
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)
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The ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions. The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
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)
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510(k) Summary for the Lutronic Corporation ADVANTAGE Laser System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Applicant: | Lutronic Corporation
219, Sowon-ro
Deogyang-gu
Goyang-si, Gyeonggi-do 410-722
Republic of Korea |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jhung Won Vojir, Ph.D.
Global Regulatory Officer
Lutronic, Inc.
6 Neshaminy Interplex, Suite 100
Trevose, PA 19053
Telephone:
215-205-2219
Fax:
609-488-6958
Email: jvojir@lutronic.com) |
| Summary Preparation Date: | June 11, 2014 |
| Names | |
| Device Name: | ADVANTAGE Laser System |
| Classification Name: | Powered laser surgical instrument |
| Regulation Name: | Laser surgical instrument for use in general
and plastic surgery and in dermatology |
| Common/Usual Name: | Pulse Diode Array Laser |
| Product Code: | GEX |
| Regulation No.: | 878.4810 |
| Class: | II |
| Panel Identification: | General & Plastic Surgery |
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3. Predicate Devices
Lutronic Corporation ADVANTAGE Laser System, cleared in 510(k) K113502 and the Lumenis Ltd. ET LighSheer 1060, cleared in 510(k) K133319.
4. Device Description
The ADVANTAGE Laser System with D1-1064 Handpiece is a treatment handpiece, intended to be used with ADVANTAGE Laser System 510(k) cleared in K113502 on April 5, 2012. The ADVANTAGE Laser System with D1-1064 Handpiece delivers laser energy through a 10 x 10 mm tip with a fluence of up to 100 J/cm2. The settings for this handpiece are pulse duration from 5-400 msec, and a pulse repetition rate up to 3 Hz maximum. The ADVANTAGE Laser System with D1-1064 Handpiece is water-cooled to provide active skin cooling.
5. Indications for Use
The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins.
The ADVANTAGE Laser System with the D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9. and 12 months.
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The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, caféau-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions.
The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles.
The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
6. Substantial Equivalence
The ADVANTAGE Laser System with D1-800 Handpiece and D3-800 Handpiece is substantially equivalent to the previously cleared ADAVANTAGE Laser System, cleared in 510(k) K113502. The ADVANTAGE Laser System with D1-800 handpiece and the D3-800 handpiece has the same intended use as the predicate device.
The ADVANTAGE Laser System with D1-1064 Handpiece has the same principles of use and mechanisms of operation as Lutronic Corporation treatment handpieces cleared in 510(k) K113502, and has equivalent performance characteristics. The materials used for ADVANTAGE Laser System with D1-1064 nm and the manufacturing methods are identical to the devices cleared in 510(k) K113502. The difference resides in the wavelength of 1064 nm for the proposed device in comparison with 805 nm for the cleared treatment handpieces. The ADVANTAGE Laser System with D1-1064 Handpiece has the same intended use and have equivalent performance characteristics as the Lumenis Ltd. ET LightSheer cleared in 510(k) K13319.
7. Performance Data
None presented.