(274 days)
No
The device description focuses on hardware components and a standard embedded processor, with no mention of AI/ML terms or functionalities like image processing or data analysis for decision making.
Yes
The device is intended for the treatment, coagulation, and ablation of various medical conditions and tissues, which are therapeutic applications.
No.
The device is described for surgical and aesthetic applications, as well as for treatments, but not for diagnosing medical conditions.
No
The device description explicitly states that the FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system, and a footswitch, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The description and intended use of the FREEDOM Laser System clearly indicate it is a therapeutic device that uses laser energy to directly treat various conditions on the human body (coagulation, hemostasis, ablation, vaporization, incision, excision). It does not involve the examination of specimens in vitro.
The device is a laser system used for surgical and aesthetic procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.
For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and striae. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.
For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
Product codes
PDZ, GEX
Device Description
The FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the FREEDOM Laser System and contains the Nd: YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.
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)
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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K113843 Page (i) of (3)
510(k) Summary for the Lutronic Corporation FREEDOM 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
Submitter:
Contact Person
Lutronic Corporation Room 403-1, 2, 3, 4, 5, 404 Ilsan Technotown 1141-1 Baekseok-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 410-722 Republic of Korea
2 7 2012
Jhung Won Vojir, Ph.D. Chief Executive Officer Lutronic, Inc. Six Neshaminy Interplex, Suite 207 Trevose, PA 19053 ivojir@lutronic.com 215-205-2219 Tele: FAX: 609-488-6958
Summary Preparation Date:
December 27, 2011
- Names
Device Name:
FREEDOM Laser System
Classification Name:
Laser instrument, surgical, powered device: GEX FDA Class II category
3. Predicate Devices
The FREEDOM Laser System is substantially equivalent to the Cutera GenesisPlus (K103626). ・・
1
4. Device Description
The FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the FREEDOM Laser System and contains the Nd: YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.
5. Indications for Use
The FREEDOM Laser System is intended for the following:
Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.
For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and straie. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.
For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
6. Substantial Equivalence
The FREEDOM Laser System is substantially equivalent to the Cutera GenesisPlus The intended use and technological characteristics of the FREEDOM Laser (K103626. System are identical to the intended use and technological characteristics of the predicate devices. Therefore, the FREEDOM Laser System is substantially equivalent the predicate device.
Confidential and Proprietary Information for Lutronic Corporation 20
2
Kira Sific Page. (3.)
7. Performance Data None presented.
.
ﺴﻴﺎ
Confidential and Proprietary Information for Lutronic Corporation 2 l
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2013
Lutronic Corporation % Lutronic Incorporated Ms. Jung Won Vojir Global Regulatory Officer 6 Neshaminy Interples, Suite 207 Trevose, Pennsylvania 19053
Re: K113843
Trade/Device Name: FREEDOM 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: PDZ, GEX Dated: September 5, 2012 Received: September 6, 2012
Dear Ms. Vojir:
This letter corrects our substantially equivalent letter of September 27, 2012.
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.
4
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 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 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/ReportalProblem/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
5
Indications for Use kil 3845
510(k) Number (if known): ___
Device Name: FREEDOM Laser System
Indications for Use:
Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.
For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and striae. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles:
For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.
For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
Prescription Use X (Part 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over The Counter Use (Part 21 CFR 801
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODEX
Page 1 of 1 (Division Sign-Off)Division of Surgical, Orthopedic, and Restorative Devices
Confidential and Proprietary Information for Lutronic Corporation 17
11384 510(k) Number